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FDA 510(k)

RADIOMHTER OSM-2 HEMOXIMETER

K-Number: K771263 · 1977-08-03

ApplicantThe London Co.
Decision Date1977-08-03
Product CodeGHS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RADIOMHTER OSM-2 HEMOXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is The London Co.. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771263. The device is classified under product code GHS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOMHTER OSM-2 HEMOXIMETER?

RADIOMHTER OSM-2 HEMOXIMETER is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is The London Co.. The 510(k) number is K771263.

When did RADIOMHTER OSM-2 HEMOXIMETER receive FDA 510(k) clearance?

RADIOMHTER OSM-2 HEMOXIMETER received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771263.

Who is the listed applicant for RADIOMHTER OSM-2 HEMOXIMETER?

The FDA 510(k) record lists The London Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIOMHTER OSM-2 HEMOXIMETER?

The FDA product code for RADIOMHTER OSM-2 HEMOXIMETER is GHS.

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Other records listing The London Co. as applicant

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.

K802846TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.K801848ICA1 IONIZED CALCIUM ANALYZERK800224RADIOMETER ACID BASE LABORATORY-ABL-3K780652HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2K771444QUALICHECK TMK760229ACID BASE SYSTEM, RADIOMETER AUTOMATED

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Related Devices (Code: GHS)

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.

K974805CO-STAT(TM) END TIDAL BREATH ANALYZERNatus Medical, Inc.K910827ABL520 BLOOD GAS SYSTEMRadiometer America, Inc.K790943TRISEDTA-BORATE ELECTROPHORESIS FILM AGACorning Medical & ScientificK770209ECOLYZER CARBOXIMETERIadec, 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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