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FDA 510(k)

RESPIRONICS VENT EASY OXYGEN ENRICHME

K-Number: K842605 · 1984-07-27

Decision Date1984-07-27
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRONICS VENT EASY OXYGEN ENRICHME is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1984-07-27 under 510(k) number K842605. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRONICS VENT EASY OXYGEN ENRICHME?

RESPIRONICS VENT EASY OXYGEN ENRICHME is a medical device that received FDA 510(k) clearance on 1984-07-27. The listed applicant is Respironics, Inc.. The 510(k) number is K842605.

When did RESPIRONICS VENT EASY OXYGEN ENRICHME receive FDA 510(k) clearance?

RESPIRONICS VENT EASY OXYGEN ENRICHME received FDA 510(k) clearance on 1984-07-27, under 510(k) number K842605.

Who is the listed applicant for RESPIRONICS VENT EASY OXYGEN ENRICHME?

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

What is the FDA product code for RESPIRONICS VENT EASY OXYGEN ENRICHME?

The FDA product code for RESPIRONICS VENT EASY OXYGEN ENRICHME is CAE.

Related Clinical Trials

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.

Other records listing Respironics, 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.

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Related Devices (Code: CAE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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