FDA 510(k)

VERTEX DIGITAL SUBSTRATION KIT

K-Number: K830637 · 1983-03-24

Decision Date1983-03-24

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VERTEX DIGITAL SUBSTRATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Professional Medical Services. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830637. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEX DIGITAL SUBSTRATION KIT?

VERTEX DIGITAL SUBSTRATION KIT is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Professional Medical Services. The 510(k) number is K830637.

When did VERTEX DIGITAL SUBSTRATION KIT receive FDA 510(k) clearance?

VERTEX DIGITAL SUBSTRATION KIT received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830637.

Who is the listed applicant for VERTEX DIGITAL SUBSTRATION KIT?

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

What is the FDA product code for VERTEX DIGITAL SUBSTRATION KIT?

The FDA product code for VERTEX DIGITAL SUBSTRATION KIT is DQO.

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Other records listing Professional Medical Services as applicant

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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.