FDA 510(k)

Comfort Cover

K-Number: K161920 · 2016-07-15

Decision Date2016-07-15

Product CodeIZH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Comfort Cover is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dynamics Corporation. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161920. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comfort Cover?

Comfort Cover is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Precision Dynamics Corporation. The 510(k) number is K161920.

When did Comfort Cover receive FDA 510(k) clearance?

Comfort Cover received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161920.

Who is the listed applicant for Comfort Cover?

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

What is the FDA product code for Comfort Cover?

The FDA product code for Comfort Cover is IZH.

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm Corporation K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic K153486Affirm Prone Biopsy SystemHologic, Inc.

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.