The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Rw Resucitaire Infant Radiant Warmer.
Device ID | K940951 |
510k Number | K940951 |
Device Name: | RW RESUCITAIRE INFANT RADIANT WARMER |
Classification | Warmer, Infant Radiant |
Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
Contact | Francis X Casey |
Correspondent | Francis X Casey AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
Product Code | FMT |
CFR Regulation Number | 880.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-02 |
Decision Date | 1995-05-03 |