FDA 510(k)

PRECISIONIST THIRTY THOUSAND

K-Number: K953447 · 1995-10-13

ApplicantParadigm Medical Industries, Inc.

Decision Date1995-10-13

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PRECISIONIST THIRTY THOUSAND is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Medical Industries, Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K953447. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISIONIST THIRTY THOUSAND?

PRECISIONIST THIRTY THOUSAND is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Paradigm Medical Industries, Inc.. The 510(k) number is K953447.

When did PRECISIONIST THIRTY THOUSAND receive FDA 510(k) clearance?

PRECISIONIST THIRTY THOUSAND received FDA 510(k) clearance on 1995-10-13, under 510(k) number K953447.

Who is the listed applicant for PRECISIONIST THIRTY THOUSAND?

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

What is the FDA product code for PRECISIONIST THIRTY THOUSAND?

The FDA product code for PRECISIONIST THIRTY THOUSAND is HQC.

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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.