FDA 510(k)

FA100 SCCD (Sequential Continuous Contraction Device)

Numéro K : K162987 · 2017-02-14

DemandeurFlowaid Medical Technologies, Corp

Date de décision2017-02-14

Code produitIPF

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

FA100 SCCD (Sequential Continuous Contraction Device) is the device name listed in this FDA 510(k) record. The listed applicant is Flowaid Medical Technologies, Corp. It received FDA 510(k) clearance on 2017-02-14 under 510(k) number K162987. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the FA100 SCCD (Sequential Continuous Contraction Device)?

FA100 SCCD (Sequential Continuous Contraction Device) is a medical device that received FDA 510(k) clearance on 2017-02-14. The listed applicant is Flowaid Medical Technologies, Corp. The 510(k) number is K162987.

When did FA100 SCCD (Sequential Continuous Contraction Device) receive FDA 510(k) clearance?

FA100 SCCD (Sequential Continuous Contraction Device) received FDA 510(k) clearance on 2017-02-14, under 510(k) number K162987.

Who is the listed applicant for FA100 SCCD (Sequential Continuous Contraction Device)?

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

What is the FDA product code for FA100 SCCD (Sequential Continuous Contraction Device)?

The FDA product code for FA100 SCCD (Sequential Continuous Contraction Device) is IPF.

Essais cliniques associés

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Source officielle

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