The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Warm Weigh Models I-20/w-30 Infant Scale.
Device ID | K872742 |
510k Number | K872742 |
Device Name: | WARM WEIGH MODELS I-20/W-30 INFANT SCALE |
Classification | Warmer, Infant Radiant |
Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
Contact | Christian Andreasen |
Correspondent | Christian Andreasen 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 | 1987-07-10 |
Decision Date | 1987-10-20 |