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FDA 510(k)

OSM-1 OXYGEN SATURATION MONITOR

K-Number: K853331 · 1986-01-14

ApplicantCriticare Systems, Inc.
Decision Date1986-01-14
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OSM-1 OXYGEN SATURATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Criticare Systems, Inc.. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K853331. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSM-1 OXYGEN SATURATION MONITOR?

OSM-1 OXYGEN SATURATION MONITOR is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K853331.

When did OSM-1 OXYGEN SATURATION MONITOR receive FDA 510(k) clearance?

OSM-1 OXYGEN SATURATION MONITOR received FDA 510(k) clearance on 1986-01-14, under 510(k) number K853331.

Who is the listed applicant for OSM-1 OXYGEN SATURATION MONITOR?

The FDA 510(k) record lists Criticare Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSM-1 OXYGEN SATURATION MONITOR?

The FDA product code for OSM-1 OXYGEN SATURATION MONITOR is JOM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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