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FDA 510(k)

UNISTIM UNT-1

K-Number: K852326 · 1985-11-14

ApplicantNeuromed, Inc.
Decision Date1985-11-14
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNISTIM UNT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Neuromed, Inc.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K852326. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNISTIM UNT-1?

UNISTIM UNT-1 is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Neuromed, Inc.. The 510(k) number is K852326.

When did UNISTIM UNT-1 receive FDA 510(k) clearance?

UNISTIM UNT-1 received FDA 510(k) clearance on 1985-11-14, under 510(k) number K852326.

Who is the listed applicant for UNISTIM UNT-1?

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

What is the FDA product code for UNISTIM UNT-1?

The FDA product code for UNISTIM UNT-1 is GZB.

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Other records listing Neuromed, Inc. as applicant

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Related Devices (Code: GZB)

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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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