The following data is part of a premarket notification filed by Gordon Consultants, Inc. with the FDA for Temp-guard Tm.
| Device ID | K790948 |
| 510k Number | K790948 |
| Device Name: | TEMP-GUARD TM |
| Classification | Warmer, Infant Radiant |
| Applicant | GORDON CONSULTANTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-21 |
| Decision Date | 1979-09-24 |