The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Warming Listhts #96h & 96ht.
Device ID | K812745 |
510k Number | K812745 |
Device Name: | WARMING LISTHTS #96H & 96HT |
Classification | Warmer, Infant Radiant |
Applicant | J. H. EMERSON CO. 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 | 1981-09-29 |
Decision Date | 1981-11-02 |