Cleared Traditional

K841687 - SKYNDEX ELECTRONIC BODY FAT CALCULA
(FDA 510(k) Clearance)

K841687 · Caldwell, Justiss & Co., Inc. · Chemistry device

Jun 1984

Decision

66d

Days

Class 1

Risk

K841687 is an FDA 510(k) clearance for the SKYNDEX ELECTRONIC BODY FAT CALCULA. This device is classified as a Caliper (Class I - General Controls, product code KTZ).

Submitted by Caldwell, Justiss & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1984, 66 days after receiving the submission on April 23, 1984.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 888.4150.

Submission Details

510(k) Number	K841687 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 23, 1984
Decision Date	June 28, 1984
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—