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FDA 510(k)

PLASMAIR, MODEL T2006

K-Number: K070722 · 2007-12-14

Decision Date2007-12-14
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLASMAIR, MODEL T2006 is the device name listed in this FDA 510(k) record. The listed applicant is Airinspace B.V.. It received FDA 510(k) clearance on 2007-12-14 under 510(k) number K070722. 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 PLASMAIR, MODEL T2006?

PLASMAIR, MODEL T2006 is a medical device that received FDA 510(k) clearance on 2007-12-14. The listed applicant is Airinspace B.V.. The 510(k) number is K070722.

When did PLASMAIR, MODEL T2006 receive FDA 510(k) clearance?

PLASMAIR, MODEL T2006 received FDA 510(k) clearance on 2007-12-14, under 510(k) number K070722.

Who is the listed applicant for PLASMAIR, MODEL T2006?

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

What is the FDA product code for PLASMAIR, MODEL T2006?

The FDA product code for PLASMAIR, MODEL T2006 is FRF.

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.

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.

Official Source

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