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FDA 510(k)

RESPIRGARD II, SPIROGARD

K-Number: K961838 · 1996-10-18

ApplicantMarquest Medical Products, Inc.
Decision Date1996-10-18
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRGARD II, SPIROGARD 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 1996-10-18 under 510(k) number K961838. 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 RESPIRGARD II, SPIROGARD?

RESPIRGARD II, SPIROGARD is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Marquest Medical Products, Inc.. The 510(k) number is K961838.

When did RESPIRGARD II, SPIROGARD receive FDA 510(k) clearance?

RESPIRGARD II, SPIROGARD received FDA 510(k) clearance on 1996-10-18, under 510(k) number K961838.

Who is the listed applicant for RESPIRGARD II, SPIROGARD?

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 RESPIRGARD II, SPIROGARD?

The FDA product code for RESPIRGARD II, SPIROGARD 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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