The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Neonate Flexfloat.
| Device ID | K812683 |
| 510k Number | K812683 |
| Device Name: | NEONATE FLEXFLOAT |
| Classification | Mattress, Water, Temperature Regulated |
| Applicant | PHARMAQUEST CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FOH |
| CFR Regulation Number | 880.5560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-22 |
| Decision Date | 1981-10-13 |