The following data is part of a premarket notification filed by Caldwell, Justiss & Co., Inc. with the FDA for Skyndex Electronic Body Fat Calcula.
Device ID | K841687 |
510k Number | K841687 |
Device Name: | SKYNDEX ELECTRONIC BODY FAT CALCULA |
Classification | Caliper |
Applicant | CALDWELL, JUSTISS & CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KTZ |
CFR Regulation Number | 888.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-06-28 |