The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Bio Clinic Under Patient Scale.
| Device ID | K925112 |
| 510k Number | K925112 |
| Device Name: | BIO CLINIC UNDER PATIENT SCALE |
| Classification | Pump, Infusion |
| Applicant | SUNRISE MEDICAL, INC. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Contact | Keith Gilroy |
| Correspondent | Keith Gilroy SUNRISE MEDICAL, INC. 4083 E. AIRPORT DR. Ontario, CA 91761 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-09 |
| Decision Date | 1993-06-18 |