Cleared Traditional

K932496 - PRECISION MED PRODUCTS, LTD. BREATHING BAGS
(FDA 510(k) Clearance)

K932496 · Precision Med Products, Ltd. · Anesthesiology

Jul 1993

Decision

52d

Days

Class 1

Risk

K932496 is an FDA 510(k) clearance for the PRECISION MED PRODUCTS, LTD. BREATHING BAGS. This device is classified as a Bag, Reservoir (Class I — General Controls, product code BTC).

Submitted by Precision Med Products, Ltd. (Marrtinsville, US). The FDA issued a Cleared decision on July 16, 1993, 52 days after receiving the submission on May 25, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5320.

Submission Details

510(k) Number	K932496 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 1993
Decision Date	July 16, 1993
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement