Cleared Traditional

K921510 - GAS SAMPLING KIT MODIFICATION
(FDA 510(k) Clearance)

K921510 · Respiratory Support Products, Inc. · Anesthesiology device

Jun 1992

Decision

90d

Days

Class 1

Risk

K921510 is an FDA 510(k) clearance for the GAS SAMPLING KIT MODIFICATION. This device is classified as a Set, Tubing And Support, Ventilator (w Harness) (Class I - General Controls, product code BZO).

Submitted by Respiratory Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on June 11, 1992, 90 days after receiving the submission on March 13, 1992.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number	K921510 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 13, 1992
Decision Date	June 11, 1992
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement