UNIPOWER RECHARGEABLE BATTERY PACK
FDA 510(k) clearance K936141 · decided 1994-03-31
Clearance details
- K-number
- K936141
- Device name
- UNIPOWER RECHARGEABLE BATTERY PACK
- Applicant
- Unipower Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-27
- Decision date
- 1994-03-31
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- BXP
- Device class
- 1
- Regulation number
- 868.2885
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| TIMOX OXYGEN TIMER (K920360) | Medical Fittings, Inc. | 1992-08-03 |
| PHONATORY FUNCTION ANALYZER PS-77 (K832678) | Kells Medical, Inc. | 1984-03-07 |
| ULTRASONIC FLOWMETER (K800087) | The Perkin-Elmer Corp. | 1980-03-19 |
| OXY-ON DIGITAL OXYGEN TIMER (K781039) | Chambers & Sadler Mfg. | 1978-08-31 |
| OXYGEN TWMER, MODEL SST (K770424) | Timeter Instrument Corp. | 1977-03-16 |
| ARIZONA OXYGEN TIMER DEVICE (K761260) | The John Bunn Co. | 1976-12-16 |
Recalls involving this device
No recalls on record reference this clearance.