TELEMETRY POWER PACK MODEL 2
FDA 510(k) clearance K891927 · decided 1990-04-26
Clearance details
- K-number
- K891927
- Device name
- TELEMETRY POWER PACK MODEL 2
- Applicant
- Lucas & Rhea Mfg.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-28
- Decision date
- 1990-04-26
- Days to decision
- 394 days
- Clearance type
- Traditional
- Product code
- FCP
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lavinia, TN, 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 |
|---|---|---|
| BATTERY PACKS (OTHER THAN CV) (K881885) | Dowit Service Co., Inc. | 1988-07-26 |
Recalls involving this device
No recalls on record reference this clearance.