PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL
FDA 510(k) clearance K934585 · decided 1993-11-03
Clearance details
- K-number
- K934585
- Device name
- PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL
- Applicant
- Lafayette Pharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-23
- Decision date
- 1993-11-03
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FCD
- Device class
- 1
- Regulation number
- 876.5210
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lafayette Pharmaceuticals
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR* (K864835) | Eisai U.S.A., Inc. | 1987-02-11 |
Recalls involving this device
No recalls on record reference this clearance.