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FDA 510(k)

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER

K-Number: K860185 · 1986-04-04

ApplicantNeuromed, Inc.
Decision Date1986-04-04
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Neuromed, Inc.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K860185. 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-1M NEUROSTIMULATOR TRANSMITTER?

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Neuromed, Inc.. The 510(k) number is K860185.

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

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER received FDA 510(k) clearance on 1986-04-04, under 510(k) number K860185.

Who is the listed applicant for UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER?

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-1M NEUROSTIMULATOR TRANSMITTER?

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

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Related Devices (Code: GZB)

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.

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK221376Nalu Neurostimulation SystemBoston Scientific NeuromodulationK203547Nalu Neurostimulation SystemBoston Scientific NeuromodulationK202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific NeuromodulationK201618Nalu Neurostimulation SCS systemBoston Scientific NeuromodulationK191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

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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