NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
FDA 510(k) clearance K961272 · decided 1996-11-01
Clearance details
- K-number
- K961272
- Device name
- NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
- Applicant
- Nihon Kohden America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-02
- Decision date
- 1996-11-01
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- LOS
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| CARDIO-CARD INTERPRETATION SYSTEM I (K993616) | Nasiff Assoc., Inc. | 2000-04-10 |
| OXYCONALPHA WITH OPTION ECG (K984465) | Erich Jaeger B.V. | 1999-10-27 |
| CASE 8000 EXERCISE TESTING SYSTEM (K991014) | General Electric Medical Systems Information Techn | 1999-10-20 |
| MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS (K991735) | General Electric Medical Systems Information Techn | 1999-08-19 |
| NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (K990031) | Nihon Kohden America, Inc. | 1999-04-16 |
| NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (K984504) | Nihon Kohden America, Inc. | 1999-04-15 |
| MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K990266) | Micromedical Industries, Ltd. | 1999-02-02 |
Recalls involving this device
No recalls on record reference this clearance.