Cleared Traditional

K880441 - PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
(FDA 510(k) Clearance)

K880441 · Plane Iii, Inc. · General & Plastic Surgery

Feb 1988

Decision

16d

Days

Class 1

Risk

K880441 is an FDA 510(k) clearance for the PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S., a Tape, Measuring, Rulers And Calipers (Class I — General Controls, product code FTY), submitted by Plane Iii, Inc. (Lebanon, US). The FDA issued a Cleared decision on February 18, 1988, 16 days after receiving the submission on February 2, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K880441 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1988
Decision Date	February 18, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—