The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Crest Electronic Warming Blanket.
| Device ID | K801253 |
| 510k Number | K801253 |
| Device Name: | CREST ELECTRONIC WARMING BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | PENLON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1981-01-02 |