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FDA 510(k)

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)

K-Number: K960309 · 1997-02-28

ApplicantAirsep Corp.
Decision Date1997-02-28
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K960309. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)?

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Airsep Corp.. The 510(k) number is K960309.

When did AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) receive FDA 510(k) clearance?

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) received FDA 510(k) clearance on 1997-02-28, under 510(k) number K960309.

Who is the listed applicant for AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)?

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

What is the FDA product code for AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)?

The FDA product code for AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) is CAW.

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Other records listing Airsep Corp. as applicant

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Related Devices (Code: CAW)

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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