NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
FDA 510(k) clearance K013133 · decided 2001-11-13
Clearance details
- K-number
- K013133
- Device name
- NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
- Applicant
- Nordix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-19
- Decision date
- 2001-11-13
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- MOQ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Phoenix, AZ, 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 |
|---|---|---|
| VERTEBRAL ACCESS SYSTEM BY VIDACARE (K081713) | Vidacare Corporation | 2008-11-21 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822 (K980224) | Alexander Mfg. Co. | 1998-04-02 |
Recalls involving this device
No recalls on record reference this clearance.