The following data is part of a premarket notification filed by Acme Medical Scale Co. with the FDA for Digital Bedside Scale #5000.
Device ID | K830171 |
510k Number | K830171 |
Device Name: | DIGITAL BEDSIDE SCALE #5000 |
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 | 1983-01-18 |
Decision Date | 1983-02-18 |