The following data is part of a premarket notification filed by Acme Medical Scale Co. with the FDA for Model 9100 H.r. Infant Scale.
Device ID | K926174 |
510k Number | K926174 |
Device Name: | MODEL 9100 H.R. INFANT SCALE |
Classification | Scale, Patient |
Applicant | ACME MEDICAL SCALE CO. 1801 ADAMS AVE. P.O. BOX 1922 San Leandro, CA 94577 |
Contact | Lou Buran |
Correspondent | Lou Buran ACME MEDICAL SCALE CO. 1801 ADAMS AVE. P.O. BOX 1922 San Leandro, CA 94577 |
Product Code | FRW |
CFR Regulation Number | 880.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-08 |
Decision Date | 1993-10-25 |