Cleared Traditional

K932562 - GAS SAMPLING LINES AND CONNECTORS
(FDA 510(k) Clearance)

Jul 1993
Decision
57d
Days
Class 1
Risk

K932562 is an FDA 510(k) clearance for the GAS SAMPLING LINES AND CONNECTORS. This device is classified as a Circuit, Breathing (w Connector, Adaptor, Y Piece) (Class I - General Controls, product code CAI).

Submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on July 23, 1993, 57 days after receiving the submission on May 27, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5240.

Submission Details

510(k) Number K932562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1993
Decision Date July 23, 1993
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAI — Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5240

Similar Devices — CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 183
CONDENSATE COLLECTION KIT
K954480 · Nova-Ventrx · Dec 1995
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
K953787 · Unicor, Inc. · Sep 1995
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
K953788 · Unicor, Inc. · Sep 1995
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K952014 · Prima, Inc. · May 1995
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
K952016 · Prima, Inc. · May 1995
PRIMA MAPLESON D CIRCUIT
K952017 · Prima, Inc. · May 1995