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FDA 510(k)

RESPIRATION RATE MONITOR 120/121

K-Number: K812044 · 1981-08-04

ApplicantMedix Medical Electronics (U.S.A.), Inc.
Decision Date1981-08-04
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION RATE MONITOR 120/121 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. It received FDA 510(k) clearance on 1981-08-04 under 510(k) number K812044. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATION RATE MONITOR 120/121?

RESPIRATION RATE MONITOR 120/121 is a medical device that received FDA 510(k) clearance on 1981-08-04. The listed applicant is Medix Medical Electronics (U.S.A.), Inc.. The 510(k) number is K812044.

When did RESPIRATION RATE MONITOR 120/121 receive FDA 510(k) clearance?

RESPIRATION RATE MONITOR 120/121 received FDA 510(k) clearance on 1981-08-04, under 510(k) number K812044.

Who is the listed applicant for RESPIRATION RATE MONITOR 120/121?

The FDA 510(k) record lists Medix Medical Electronics (U.S.A.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRATION RATE MONITOR 120/121?

The FDA product code for RESPIRATION RATE MONITOR 120/121 is BZQ.

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Other records listing Medix Medical Electronics (U.S.A.), Inc. as applicant

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K861040ENTERNAL INFUSER MULTIPUMP 203K861001PARENTERAL INFUSER MEDIPUMP 204K853393INSULIN PUMP INSUMAT 229K852433INFUSAFE 205 CATOLOG NO. 205.000K813562SYRINGE DRIVER 209K812039SPIROMETER 210/211

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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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