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FDA 510(k)

AIRSONETT AIR-4

K-Number: K130702 · 2013-07-23

ApplicantAirsonett AB
Decision Date2013-07-23
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AIRSONETT AIR-4 is the device name listed in this FDA 510(k) record. The listed applicant is Airsonett AB. It received FDA 510(k) clearance on 2013-07-23 under 510(k) number K130702. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRSONETT AIR-4?

AIRSONETT AIR-4 is a medical device that received FDA 510(k) clearance on 2013-07-23. The listed applicant is Airsonett AB. The 510(k) number is K130702.

When did AIRSONETT AIR-4 receive FDA 510(k) clearance?

AIRSONETT AIR-4 received FDA 510(k) clearance on 2013-07-23, under 510(k) number K130702.

Who is the listed applicant for AIRSONETT AIR-4?

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

What is the FDA product code for AIRSONETT AIR-4?

The FDA product code for AIRSONETT AIR-4 is FRF.

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Related Devices (Code: FRF)

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

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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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