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FDA 510(k)

OSM3 HEMOXIMETER

K-Number: K853990 · 1985-12-30

ApplicantRadiometer America, Inc.
Decision Date1985-12-30
Product CodeJKS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OSM3 HEMOXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1985-12-30 under 510(k) number K853990. The device is classified under product code JKS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSM3 HEMOXIMETER?

OSM3 HEMOXIMETER is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Radiometer America, Inc.. The 510(k) number is K853990.

When did OSM3 HEMOXIMETER receive FDA 510(k) clearance?

OSM3 HEMOXIMETER received FDA 510(k) clearance on 1985-12-30, under 510(k) number K853990.

Who is the listed applicant for OSM3 HEMOXIMETER?

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

What is the FDA product code for OSM3 HEMOXIMETER?

The FDA product code for OSM3 HEMOXIMETER is JKS.

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Other records listing Radiometer America, Inc. as applicant

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Related Devices (Code: JKS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951485AVOXIMETER 4000A-Vox Systems, Inc.K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific IndustriesK862253IL 482 CO-OXIMETERInstrumentation Laboratory COK833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.K833211BILE SALTS MIXTUREAcumedia Manufacturers, Inc.K832066CONTROL 282Bio-Nustics, Inc.

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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