The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Warm Weigh Model N-10 Infant Scale.
Device ID | K870888 |
510k Number | K870888 |
Device Name: | WARM WEIGH MODEL N-10 INFANT SCALE |
Classification | Scale, Patient |
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 | FRW |
CFR Regulation Number | 880.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-05 |
Decision Date | 1987-03-17 |