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FDA 510(k)

RESPIRATION MONITOR 1000

K-Number: K820778 · 1982-05-03

ApplicantIntl. Medical Devices , Ltd.
Decision Date1982-05-03
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION MONITOR 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Devices , Ltd.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K820778. 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 MONITOR 1000?

RESPIRATION MONITOR 1000 is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Intl. Medical Devices , Ltd.. The 510(k) number is K820778.

When did RESPIRATION MONITOR 1000 receive FDA 510(k) clearance?

RESPIRATION MONITOR 1000 received FDA 510(k) clearance on 1982-05-03, under 510(k) number K820778.

Who is the listed applicant for RESPIRATION MONITOR 1000?

The FDA 510(k) record lists Intl. Medical Devices , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRATION MONITOR 1000?

The FDA product code for RESPIRATION MONITOR 1000 is BZQ.

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Other records listing Intl. Medical Devices , Ltd. as applicant

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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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