The following data is part of a premarket notification filed by Clinical Data Instruments, Inc. with the FDA for Neo-float Neonatal Flotation Sys & Rhyt.
| Device ID | K832829 |
| 510k Number | K832829 |
| Device Name: | NEO-FLOAT NEONATAL FLOTATION SYS & RHYT |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | CLINICAL DATA INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1983-10-04 |