FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDIO BANDWIDTH ANALYZER
K Number: K840402
·
Decision May 9, 1984
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
19
Review Days
99
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
- AUDIO BANDWIDTH ANALYZER
- K Number
- K840402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- D. E. Hokanson, Inc.
- Date Received
- January 31, 1984
- Decision Date
- May 9, 1984
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYN), ordered by most recent decision date.
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ES-Series
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
LOGIQ e
FDA 510(k)
FDA Class 2
·Radiology
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by D. E. Hokanson, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041689 | POLYURETHANE BLOOD PRESSURE CUFFS | Aug 6, 2004 | Substantially Equivalent |
| K033156 | OB1 OBSTETRICAL DOPPLER | Dec 9, 2003 | Substantially Equivalent |
| K023707 | A16 BLOOD FLOW MEASUREMENT SYSTEM | Feb 12, 2003 | Substantially Equivalent |
| K982707 | EC6 PLETHYSMOGRAPH | Aug 26, 1998 | Substantially Equivalent |
| K973426 | ANS 2000 ECG MONITOR AND RESPIRATION PACER | Aug 12, 1998 | Substantially Equivalent |
| K970570 | NIVP3 (WINDOWS VERSION OF NIVP | Oct 3, 1997 | Substantially Equivalent |
| K932852 | NON INVASIVE VASCULAR PROGRAM | Feb 4, 1994 | Substantially Equivalent |
| K932812 | EC 5R PLETHYSMOGRAPH | Jan 13, 1994 | Substantially Equivalent |
| K932851 | DISPOSABLE PENILE BLOOD PRESSURE CUFFS | Nov 15, 1993 | Substantially Equivalent |
| K905367 | E-20 RAPID CUFF INFLATOR | Mar 6, 1991 | Substantially Equivalent |