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FDA 510(k)

RESPIR GARD-II OXYGARD HYDROGARD-SPIRO

K-Number: K833267 · 1983-10-28

ApplicantMarquest Medical Products, Inc.
Decision Date1983-10-28
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIR GARD-II OXYGARD HYDROGARD-SPIRO is the device name listed in this FDA 510(k) record. The listed applicant is Marquest Medical Products, Inc.. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K833267. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIR GARD-II OXYGARD HYDROGARD-SPIRO?

RESPIR GARD-II OXYGARD HYDROGARD-SPIRO is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Marquest Medical Products, Inc.. The 510(k) number is K833267.

When did RESPIR GARD-II OXYGARD HYDROGARD-SPIRO receive FDA 510(k) clearance?

RESPIR GARD-II OXYGARD HYDROGARD-SPIRO received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833267.

Who is the listed applicant for RESPIR GARD-II OXYGARD HYDROGARD-SPIRO?

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

What is the FDA product code for RESPIR GARD-II OXYGARD HYDROGARD-SPIRO?

The FDA product code for RESPIR GARD-II OXYGARD HYDROGARD-SPIRO is CAH.

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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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