FDA 510(k)

MEDA ONE-STEP

K-Number: K882943 · 1988-08-19

Decision Date1988-08-19

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDA ONE-STEP is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Assn.. It received FDA 510(k) clearance on 1988-08-19 under 510(k) number K882943. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDA ONE-STEP?

MEDA ONE-STEP is a medical device that received FDA 510(k) clearance on 1988-08-19. The listed applicant is Medical Electronic Assn.. The 510(k) number is K882943.

When did MEDA ONE-STEP receive FDA 510(k) clearance?

MEDA ONE-STEP received FDA 510(k) clearance on 1988-08-19, under 510(k) number K882943.

Who is the listed applicant for MEDA ONE-STEP?

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

What is the FDA product code for MEDA ONE-STEP?

The FDA product code for MEDA ONE-STEP is GZJ.

Other records listing Medical Electronic Assn. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K913800MEDA CROWN SERIES K862011MULTI-DAY ELECTRODES

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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.