NARKOMED 6000
FDA 510(k) clearance K993826 · decided 2000-03-23
Clearance details
- K-number
- K993826
- Device name
- NARKOMED 6000
- Applicant
- Draeger Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-12
- Decision date
- 2000-03-23
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- MLC
- Device class
- 2
- Regulation number
- 870.2340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Telford, PA, US
- 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 |
|---|---|---|
| DATASCOPE 6000 MONITOR (K926099) | Datascope Corp. | 1993-08-06 |
Recalls involving this device
No recalls on record reference this clearance.