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FDA 510(k)

ULTRASONIC BIO-MICROSCOPE, MODEL P60

K-Number: K050980 · 2005-05-26

ApplicantParadigm Medical Industries, Inc.
Decision Date2005-05-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC BIO-MICROSCOPE, MODEL P60 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 2005-05-26 under 510(k) number K050980. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC BIO-MICROSCOPE, MODEL P60?

ULTRASONIC BIO-MICROSCOPE, MODEL P60 is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Paradigm Medical Industries, Inc.. The 510(k) number is K050980.

When did ULTRASONIC BIO-MICROSCOPE, MODEL P60 receive FDA 510(k) clearance?

ULTRASONIC BIO-MICROSCOPE, MODEL P60 received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050980.

Who is the listed applicant for ULTRASONIC BIO-MICROSCOPE, MODEL P60?

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 ULTRASONIC BIO-MICROSCOPE, MODEL P60?

The FDA product code for ULTRASONIC BIO-MICROSCOPE, MODEL P60 is IYO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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