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FDA 510(k)

Presygen/si-1

K-Number: K171245 · 2018-08-09

ApplicantChristie Medical Holdings, Inc.
Decision Date2018-08-09
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Presygen/si-1 is a medical device manufactured by Christie Medical Holdings, Inc.. It received FDA 510(k) clearance on 2018-08-09 under approval number K171245. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Presygen/si-1?

Presygen/si-1 is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Christie Medical Holdings, Inc.. The 510(k) number is K171245.

When was Presygen/si-1 approved by the FDA?

Presygen/si-1 received FDA 510(k) clearance on 2018-08-09, under approval number K171245.

What company makes Presygen/si-1?

Presygen/si-1 is manufactured by Christie Medical Holdings, Inc..

What is the FDA product code for Presygen/si-1?

The FDA product code for Presygen/si-1 is MUD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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