Cleared Traditional

K943837 - CHIN UP
(FDA 510(k) Clearance)

Oct 1994
Decision
70d
Days
Class 1
Risk

K943837 is an FDA 510(k) clearance for the CHIN UP. This device is classified as a Support, Patient Position (Class I - General Controls, product code CCX).

Submitted by Edward Carden (Marina Del Rey, US). The FDA issued a Cleared decision on October 14, 1994, 70 days after receiving the submission on August 5, 1994.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6820.

Submission Details

510(k) Number K943837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1994
Decision Date October 14, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CCX — Support, Patient Position
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.6820

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