FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHYTHMSCAN
K Number: K871572
·
Decision Feb 22, 1988
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
21
Review Days
306
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RHYTHMSCAN
- K Number
- K871572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Brentwood Instruments, Inc.
- Date Received
- April 22, 1987
- Decision Date
- February 22, 1988
- Product Code
- DSI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSI), ordered by most recent decision date.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Brentwood Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896924 | SPIROSCAN 4000 | Mar 1, 1990 | Substantially Equivalent |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | Aug 2, 1988 | Substantially Equivalent |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | Mar 31, 1986 | Substantially Equivalent |
| K853979 | CARDIMAX FX-1164 | Feb 6, 1986 | Substantially Equivalent |
| K854505 | CARDIMAX FX-406U | Feb 4, 1986 | Substantially Equivalent |
| K851135 | SPIRO SCAN | Jul 1, 1985 | Substantially Equivalent |
| K851124 | T-1000 ECG TRANSMITTER | May 15, 1985 | Substantially Equivalent |
| K851123 | R-1000 ECG RECEIVER | May 15, 1985 | Substantially Equivalent |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | Mar 1, 1985 | Substantially Equivalent |
| K844470 | FUKUDA DENSHI MODEL FCP-220 | Jan 10, 1985 | Substantially Equivalent |