The following data is part of a premarket notification filed by Arco Medical Products Co. with the FDA for Decubitus Mattress.
| Device ID | K760963 |
| 510k Number | K760963 |
| Device Name: | DECUBITUS MATTRESS |
| Classification | Mattress, Flotation Therapy, Non-powered |
| Applicant | ARCO MEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IKY |
| CFR Regulation Number | 880.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-04 |
| Decision Date | 1976-11-18 |