OSM-1 OXYGEN SATURATION MONITOR— 510(k) K853331

Substantially Equivalent

Criticare Systems, Inc.

FDA 510(k) clearance K853331 for OSM-1 OXYGEN SATURATION MONITOR, Substantially Equivalent on 1986-01-14. Applicant: Criticare Systems, Inc..

Clearance details

Applicant: Criticare Systems, Inc.
Product code: Code JOM
Advisory panel: Cardiovascular
Date received: 1985-08-08
Decision date: 1986-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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