SPIROLOOP
FDA 510(k) clearance K841858 · decided 1984-07-11
Clearance details
- K-number
- K841858
- Device name
- SPIROLOOP
- Applicant
- Datamed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-04
- Decision date
- 1984-07-11
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- BSE
- Device class
- 2
- Regulation number
- 868.1640
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, 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 |
|---|---|---|
| PANDA HELIUM GAS ANALYZER (K903939) | Medical Associated Services, Inc. | 1991-01-03 |
| HE TEST (K843843) | Erich Jaeger, Inc. | 1984-12-04 |
Recalls involving this device
No recalls on record reference this clearance.