FDA 510(k)

MICROMEDIC SYSTEMS ISOFLEX

K-Number: K820376 · 1982-03-16

Decision Date1982-03-16

Product CodeJJJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MICROMEDIC SYSTEMS ISOFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1982-03-16 under 510(k) number K820376. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMEDIC SYSTEMS ISOFLEX?

MICROMEDIC SYSTEMS ISOFLEX is a medical device that received FDA 510(k) clearance on 1982-03-16. The listed applicant is Micromedic Systems. The 510(k) number is K820376.

When did MICROMEDIC SYSTEMS ISOFLEX receive FDA 510(k) clearance?

MICROMEDIC SYSTEMS ISOFLEX received FDA 510(k) clearance on 1982-03-16, under 510(k) number K820376.

Who is the listed applicant for MICROMEDIC SYSTEMS ISOFLEX?

The FDA 510(k) record lists Micromedic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROMEDIC SYSTEMS ISOFLEX?

The FDA product code for MICROMEDIC SYSTEMS ISOFLEX is JJJ.

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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.