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FDA 510(k)

PROFLEX

K-Number: K821672 · 1982-07-22

ApplicantUtah Medical Products, Inc.
Decision Date1982-07-22
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products, Inc.. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K821672. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFLEX?

PROFLEX is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K821672.

When did PROFLEX receive FDA 510(k) clearance?

PROFLEX received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821672.

Who is the listed applicant for PROFLEX?

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

What is the FDA product code for PROFLEX?

The FDA product code for PROFLEX is HRX.

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Other records listing Utah Medical Products, Inc. as applicant

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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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