UFR DIGITAL RETROFIT
FDA 510(k) clearance K875312 · decided 1988-02-19
Clearance details
- K-number
- K875312
- Device name
- UFR DIGITAL RETROFIT
- Applicant
- Yankee Intl. Medical Research & Mfg., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-29
- Decision date
- 1988-02-19
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- FJB
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Manchese, NH, 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 |
|---|---|---|
| ACCUFLO UF CONTROL MODULE NO. 74-0100-3 (K883490) | National Medical Care, Medical Products Div., Inc. | 1988-09-29 |
| CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 (K881062) | Cobe Laboratories, Inc. | 1988-04-21 |
Recalls involving this device
No recalls on record reference this clearance.