FDA 510(k)

PRIME PCA AND PCA/CONTINUOUS SYSTEMS

K-Number: K920637 · 1993-01-15

Decision Date1993-01-15

Product CodeMEA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRIME PCA AND PCA/CONTINUOUS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Prime Medical Products, Inc.. It received FDA 510(k) clearance on 1993-01-15 under 510(k) number K920637. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME PCA AND PCA/CONTINUOUS SYSTEMS?

PRIME PCA AND PCA/CONTINUOUS SYSTEMS is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Prime Medical Products, Inc.. The 510(k) number is K920637.

When did PRIME PCA AND PCA/CONTINUOUS SYSTEMS receive FDA 510(k) clearance?

PRIME PCA AND PCA/CONTINUOUS SYSTEMS received FDA 510(k) clearance on 1993-01-15, under 510(k) number K920637.

Who is the listed applicant for PRIME PCA AND PCA/CONTINUOUS SYSTEMS?

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

What is the FDA product code for PRIME PCA AND PCA/CONTINUOUS SYSTEMS?

The FDA product code for PRIME PCA AND PCA/CONTINUOUS SYSTEMS is MEA.

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Other records listing Prime Medical Products, Inc. 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.