Cleared Traditional

K934235 - SNIFF POSITION PILLOW
(FDA 510(k) Clearance)

K934235 · American Medical Development, Inc. · Anesthesiology

Oct 1993

Decision

32d

Days

Class 1

Risk

K934235 is an FDA 510(k) clearance for the SNIFF POSITION PILLOW. This device is classified as a Support, Patient Position (Class I — General Controls, product code CCX).

Submitted by American Medical Development, Inc. (Boston, US). The FDA issued a Cleared decision on October 1, 1993, 32 days after receiving the submission on August 30, 1993.

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

Submission Details

510(k) Number	K934235 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 30, 1993
Decision Date	October 01, 1993
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement