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FDA 510(k)

ECOLYZER CARBOXIMETER

K-Number: K770209 · 1977-03-07

ApplicantIadec, Inc.
Decision Date1977-03-07
Product CodeGHS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ECOLYZER CARBOXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Iadec, Inc.. It received FDA 510(k) clearance on 1977-03-07 under 510(k) number K770209. 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 ECOLYZER CARBOXIMETER?

ECOLYZER CARBOXIMETER is a medical device that received FDA 510(k) clearance on 1977-03-07. The listed applicant is Iadec, Inc.. The 510(k) number is K770209.

When did ECOLYZER CARBOXIMETER receive FDA 510(k) clearance?

ECOLYZER CARBOXIMETER received FDA 510(k) clearance on 1977-03-07, under 510(k) number K770209.

Who is the listed applicant for ECOLYZER CARBOXIMETER?

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

What is the FDA product code for ECOLYZER CARBOXIMETER?

The FDA product code for ECOLYZER CARBOXIMETER is GHS.

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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 & ScientificK771263RADIOMHTER OSM-2 HEMOXIMETERThe London Co.

Official Source

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

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