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FDA 510(k)

PREMIER

K-Number: K942437 · 1994-06-15

ApplicantPremier Medical Industries, Inc.
Decision Date1994-06-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREMIER is the device name listed in this FDA 510(k) record. The listed applicant is Premier Medical Industries, Inc.. It received FDA 510(k) clearance on 1994-06-15 under 510(k) number K942437. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER?

PREMIER is a medical device that received FDA 510(k) clearance on 1994-06-15. The listed applicant is Premier Medical Industries, Inc.. The 510(k) number is K942437.

When did PREMIER receive FDA 510(k) clearance?

PREMIER received FDA 510(k) clearance on 1994-06-15, under 510(k) number K942437.

Who is the listed applicant for PREMIER?

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

What is the FDA product code for PREMIER?

The FDA product code for PREMIER is LYY.

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Related Devices (Code: LYY)

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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.

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