Cleared Traditional

K884329 - SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER (FDA 510(k) Clearance)

K884329 · Baxter Healthcare Corp · Anesthesiology device

Dec 1988

Decision

63d

Days

Class 2

Risk

K884329 is an FDA 510(k) clearance for the SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 16, 1988, 63 days after receiving the submission on October 14, 1988.

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

Submission Details

510(k) Number	K884329 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 14, 1988
Decision Date	December 16, 1988
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—