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FDA 510(k)

MEDDARS/ULTRA IMAGER RESPIRATION MODULE

K-Number: K812667 · 1981-10-23

ApplicantHoneywell, Inc.
Decision Date1981-10-23
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDDARS/ULTRA IMAGER RESPIRATION MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812667. 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 MEDDARS/ULTRA IMAGER RESPIRATION MODULE?

MEDDARS/ULTRA IMAGER RESPIRATION MODULE is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Honeywell, Inc.. The 510(k) number is K812667.

When did MEDDARS/ULTRA IMAGER RESPIRATION MODULE receive FDA 510(k) clearance?

MEDDARS/ULTRA IMAGER RESPIRATION MODULE received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812667.

Who is the listed applicant for MEDDARS/ULTRA IMAGER RESPIRATION MODULE?

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

What is the FDA product code for MEDDARS/ULTRA IMAGER RESPIRATION MODULE?

The FDA product code for MEDDARS/ULTRA IMAGER RESPIRATION MODULE is BZQ.

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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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