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FDA 510(k)

RESPIRGARD II NEBULIZER SYSTEM

K-Number: K874395 · 1987-12-21

ApplicantMarquest Medical Products, Inc.
Decision Date1987-12-21
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRGARD II NEBULIZER SYSTEM 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 1987-12-21 under 510(k) number K874395. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRGARD II NEBULIZER SYSTEM?

RESPIRGARD II NEBULIZER SYSTEM is a medical device that received FDA 510(k) clearance on 1987-12-21. The listed applicant is Marquest Medical Products, Inc.. The 510(k) number is K874395.

When did RESPIRGARD II NEBULIZER SYSTEM receive FDA 510(k) clearance?

RESPIRGARD II NEBULIZER SYSTEM received FDA 510(k) clearance on 1987-12-21, under 510(k) number K874395.

Who is the listed applicant for RESPIRGARD II NEBULIZER SYSTEM?

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 NEBULIZER SYSTEM?

The FDA product code for RESPIRGARD II NEBULIZER SYSTEM is CAF.

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Other records listing Marquest Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050066C-CO2 COLORIMETRIC CO2 INDICATORK970478SCT 3000 HEATED HUMIDIFIERK962223WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIERK962220HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIERK960972DISPOSABLE GAS SAMPLING INTERFACE KITSK961838RESPIRGARD II, SPIROGARD

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Related Devices (Code: CAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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