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 the device name listed in this FDA 510(k) record. The listed applicant is Christie Medical Holdings, Inc.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) 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. The listed applicant is Christie Medical Holdings, Inc.. The 510(k) number is K171245.

When did Presygen/si-1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Presygen/si-1?

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

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

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

Related Devices (Code: MUD)

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.

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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.