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FDA 510(k)

FA100 SCCD (Sequential Continuous Contraction Device)

K-Number: K162987 · 2017-02-14

ApplicantFlowaid Medical Technologies, Corp
Decision Date2017-02-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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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