The following data is part of a premarket notification filed by Acme Medical Scale Co. with the FDA for Acme Digital Infant Scale-30.
Device ID | K841534 |
510k Number | K841534 |
Device Name: | ACME DIGITAL INFANT SCALE-30 |
Classification | Scale, Patient |
Applicant | ACME MEDICAL SCALE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRW |
CFR Regulation Number | 880.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-16 |
Decision Date | 1984-05-31 |