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FDA 510(k)

AIRSEP IMPULSE

K-Number: K962766 · 1996-10-10

ApplicantAirsep Corp.
Decision Date1996-10-10
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRSEP IMPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K962766. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRSEP IMPULSE?

AIRSEP IMPULSE is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Airsep Corp.. The 510(k) number is K962766.

When did AIRSEP IMPULSE receive FDA 510(k) clearance?

AIRSEP IMPULSE received FDA 510(k) clearance on 1996-10-10, under 510(k) number K962766.

Who is the listed applicant for AIRSEP IMPULSE?

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 IMPULSE?

The FDA product code for AIRSEP IMPULSE is NFB.

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Other records listing Airsep Corp. 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.

K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LK080348OXISCAN II DATA MANAGEMENT SYSTEMK020324LIFESTYLE OXYGEN CONCENTRATORK012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009K000963DA VINCHI EEG AND EMG/EP SYSTEMSK001579IMPULSE SELECT

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Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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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