The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Bio Flote(r).
| Device ID | K900131 |
| 510k Number | K900131 |
| Device Name: | BIO FLOTE(R) |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | BIO CLINIC CO. P.O. BOX 1528 10670 ACACIA STREET Rancho Cucamonga, CA 91730 |
| Contact | Gilroy, Phd |
| Correspondent | Gilroy, Phd BIO CLINIC CO. P.O. BOX 1528 10670 ACACIA STREET Rancho Cucamonga, CA 91730 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-10 |
| Decision Date | 1990-02-16 |