Cleared Traditional

K862885 - CAR SEAT (FDA 510(k) Clearance)

Aug 1986
Decision
23d
Days
Class 1
Risk

K862885 is an FDA 510(k) clearance for the CAR SEAT. This device is classified as a Chair, Adjustable, Mechanical (Class I - General Controls, product code INN).

Submitted by Mednet, Inc. (Battle Creek, US). The FDA issued a Cleared decision on August 14, 1986, 23 days after receiving the submission on July 22, 1986.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K862885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 14, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code INN — Chair, Adjustable, Mechanical
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3100

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