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FDA 510(k)

PULSAR NEUROSTIMULATOR

K-Number: K852061 · 1986-07-18

ApplicantAndromeda Research, Inc.
Decision Date1986-07-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PULSAR NEUROSTIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Andromeda Research, Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K852061. 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 PULSAR NEUROSTIMULATOR?

PULSAR NEUROSTIMULATOR is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Andromeda Research, Inc.. The 510(k) number is K852061.

When did PULSAR NEUROSTIMULATOR receive FDA 510(k) clearance?

PULSAR NEUROSTIMULATOR received FDA 510(k) clearance on 1986-07-18, under 510(k) number K852061.

Who is the listed applicant for PULSAR NEUROSTIMULATOR?

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

What is the FDA product code for PULSAR NEUROSTIMULATOR?

The FDA product code for PULSAR NEUROSTIMULATOR is GZJ.

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Related Devices (Code: GZJ)

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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.

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