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FDA 510(k)

AIRSEP NEWLIFE AIR OUTLET OPTION

K-Number: K944020 · 1995-03-16

ApplicantAirsep Corp.
Decision Date1995-03-16
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRSEP NEWLIFE AIR OUTLET OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1995-03-16 under 510(k) number K944020. 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 AIRSEP NEWLIFE AIR OUTLET OPTION?

AIRSEP NEWLIFE AIR OUTLET OPTION is a medical device that received FDA 510(k) clearance on 1995-03-16. The listed applicant is Airsep Corp.. The 510(k) number is K944020.

When did AIRSEP NEWLIFE AIR OUTLET OPTION receive FDA 510(k) clearance?

AIRSEP NEWLIFE AIR OUTLET OPTION received FDA 510(k) clearance on 1995-03-16, under 510(k) number K944020.

Who is the listed applicant for AIRSEP NEWLIFE AIR OUTLET OPTION?

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 AIR OUTLET OPTION?

The FDA product code for AIRSEP NEWLIFE AIR OUTLET OPTION is CAF.

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Other records listing Airsep Corp. as applicant

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Related Devices (Code: CAF)

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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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