PANDA HELIUM GAS ANALYZER
FDA 510(k) clearance K903939 · decided 1991-01-03
Clearance details
- K-number
- K903939
- Device name
- PANDA HELIUM GAS ANALYZER
- Applicant
- Medical Associated Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-27
- Decision date
- 1991-01-03
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- BSE
- Device class
- 2
- Regulation number
- 868.1640
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hatfield, 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 |
|---|---|---|
| HE TEST (K843843) | Erich Jaeger, Inc. | 1984-12-04 |
| SPIROLOOP (K841858) | Datamed, Inc. | 1984-07-11 |
Recalls involving this device
No recalls on record reference this clearance.