FDA 510(k)

HEMOGLOBINOMETER

K-Number: K832288 · 1983-09-01

Decision Date1983-09-01

Product CodeKMG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HEMOGLOBINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832288. The device is classified under product code KMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBINOMETER?

HEMOGLOBINOMETER is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K832288.

When did HEMOGLOBINOMETER receive FDA 510(k) clearance?

HEMOGLOBINOMETER received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832288.

Who is the listed applicant for HEMOGLOBINOMETER?

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

What is the FDA product code for HEMOGLOBINOMETER?

The FDA product code for HEMOGLOBINOMETER is KMG.

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Other records listing Mallinckrodt Critical Care as applicant

K880343BURNEY GALLBLADDER CATHETER KIT K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR K874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE K874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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Related Devices (Code: KMG)

K012029REMEDY MODEL 2Z12Apollo Corp.K831253LANCER HEMOGLOBIN ANALYZER REAGENTSSherwood Medical Co.K813045AQUANOMICS, #SP36SFCooper-Hewitt Electric Co.K813049AQUANOMICS, #HHU100Cooper-Hewitt Electric Co.K813047AQUANOMICS, MINI 60LCooper-Hewitt Electric Co.K813048AQUANOMICS, #MP2SFCooper-Hewitt Electric Co.

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.