Product Code: DRR FDA class 2 21 CFR 870.2050

Amplifier And Signal Conditioner, Biopotential

Cardiovascular

The Biopotential Amplifier and Signal Conditioner is a cardiovascular electronic device used to amplify and filter weak bioelectric signals such as ECG or intracardiac electrograms, making them suitable for display, recording, or further analysis. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRR and it is regulated under 21 CFR 870.2050 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DRR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DRR
Device Class: FDA class 2
Regulation Number: 870.2050
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K022660	BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117	Dec 19, 2002	Substantially Equivalent	Biocheck, Inc.
K971570	EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391	Dec 29, 1997	Substantially Equivalent	Quinton Electrophysiology Corp.
K925346	EP AMP, MODEL #901	Apr 30, 1993	Substantially Equivalent	Quinton Electrophysiology Corp.
K914381	HORIZON 9000/HIS OPTION AMPLIFIER	Jan 28, 1992	Substantially Equivalent	Mennen Medical, Inc.
K911935	CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED	Jul 22, 1991	Substantially Equivalent	Gould, Inc.
K910307	CARDIOLAB AMPLIFIER MODULE (CAM)	Apr 12, 1991	Substantially Equivalent	Prucka Engineering, Inc.
K894735	ASC-952 PHYSIOLOGICAL AMPLIFIER	Sep 18, 1989	Substantially Equivalent	Astro-Med, Inc.
K894161	ASC-950 ECG AMPLIFIER	Aug 03, 1989	Substantially Equivalent	Astro-Med, Inc.
K874441	BARD BIOPOTENTIAL AMPLIFIER	Jan 19, 1988	Substantially Equivalent	C.R. Bard, Inc.
K853652	BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT	Jan 16, 1986	Substantially Equivalent	Fisher Imaging Corp.
K813123	EPC FILTER	Nov 27, 1981	Substantially Equivalent	Codman & Shurtleff, Inc.
K810828	NON-INVASIVE AMPLIFIER	Apr 10, 1981	Substantially Equivalent	Henry Ford Hospital
K802686	HP MODEL 8880A FILTER	Nov 26, 1980	Substantially Equivalent	Hewlett-Packard Co.
K802282	ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON	Oct 10, 1980	Substantially Equivalent	Consolidated Medical Equipment, Inc.
K792283	ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON	Nov 21, 1979	Substantially Equivalent	Arzbaecher & Co.
K791964	MODEL 15055A MAINFRAME	Oct 11, 1979	Substantially Equivalent	Hewlett-Packard Co.
K790203	INTERVAL TIMER MODEL V4295	Mar 02, 1979	Substantially Equivalent	Electronics For Medicine, Inc.
K780572	DCG PREAMPLIFIER MODULE	May 09, 1978	Substantially Equivalent	C-V Monitors Corp.
K780043	ESIS MODULE	Feb 13, 1978	Substantially Equivalent	Datascope Corp.
K772132	AMPLIFIER MODULE, 78211A ECG	Nov 22, 1977	Substantially Equivalent	Hewlett-Packard Co.
K771976	ECG AMPLIFIER/R WAVE TRIGGER	Nov 09, 1977	Substantially Equivalent	G.D. Searle and Co.
K771572	PATIENT MONITORS MODELS 78701A/78702A	Aug 30, 1977	Substantially Equivalent	Hewlett-Packard Co.
K770243	ELGILOY STYLET	Feb 14, 1977	Substantially Equivalent	Cardiac Pacemakers, Inc.
K761056	DISPLAY MONITOR (MODEL 78301A)	Dec 09, 1976	Substantially Equivalent	Hewlett-Packard Co.