CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
FDA 510(k) clearance K902493 · decided 1990-07-06
Clearance details
- K-number
- K902493
- Device name
- CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
- Applicant
- Datex Division Instrumentarium Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-05
- Decision date
- 1990-07-06
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- DRI
- Device class
- 1
- Regulation number
- 870.2620
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Helsinki, Finland, FI
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S (K902492) | Datex Division Instrumentarium Corp. | 1990-07-06 |
| HEART MONITOR BRACELET ALARM (K822316) | Hmba | 1982-09-21 |
| PRESSURE MONITORING LINES (K802326) | Stanco Medical, Inc. | 1980-10-10 |
Recalls involving this device
No recalls on record reference this clearance.