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FDA 510(k)

Cianna Medical SAVI Scout Reflector and SAVI Scout System

K-Number: K161507 · 2016-07-29

Decision Date2016-07-29
Product CodePDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cianna Medical SAVI Scout Reflector and SAVI Scout System is the device name listed in this FDA 510(k) record. The listed applicant is Cianna Medical, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161507. The device is classified under product code PDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cianna Medical SAVI Scout Reflector and SAVI Scout System?

Cianna Medical SAVI Scout Reflector and SAVI Scout System is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Cianna Medical, Inc.. The 510(k) number is K161507.

When did Cianna Medical SAVI Scout Reflector and SAVI Scout System receive FDA 510(k) clearance?

Cianna Medical SAVI Scout Reflector and SAVI Scout System received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161507.

Who is the listed applicant for Cianna Medical SAVI Scout Reflector and SAVI Scout System?

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

What is the FDA product code for Cianna Medical SAVI Scout Reflector and SAVI Scout System?

The FDA product code for Cianna Medical SAVI Scout Reflector and SAVI Scout System is PDW.

Other records listing Cianna Medical, Inc. as applicant

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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