Cleared Traditional

K972829 - CRICKET 2000 RECORDING PULSE OXIMETER (FDA 510(k) Clearance)

K972829 · Respironics, Inc. · Anesthesiology device

Oct 1997

Decision

90d

Days

Class 2

Risk

K972829 is an FDA 510(k) clearance for the CRICKET 2000 RECORDING PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 28, 1997, 90 days after receiving the submission on July 30, 1997.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K972829 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 30, 1997
Decision Date	October 28, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF