SPIRIT, MODEL HAS
FDA 510(k) clearance K050153 · decided 2005-04-15
Clearance details
- K-number
- K050153
- Device name
- SPIRIT, MODEL HAS
- Applicant
- Caire, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-24
- Decision date
- 2005-04-15
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- BYJ
- Device class
- 2
- Regulation number
- 868.5655
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and H recall (Z-1716-2008) | Caire, Inc. | 2008-08-26 |