The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Flexfloat Heater.
| Device ID | K812682 |
| 510k Number | K812682 |
| Device Name: | FLEXFLOAT HEATER |
| Classification | Mattress, Water, Temperature Regulated |
| Applicant | PHARMAQUEST CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| 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 | 1981-10-08 |