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FDA 510(k)

NEUROPAC ULTRA I

K-Number: K810593 · 1981-03-13

ApplicantMedical Devices, Inc.
Decision Date1981-03-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPAC ULTRA I is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810593. 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 NEUROPAC ULTRA I?

NEUROPAC ULTRA I is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Medical Devices, Inc.. The 510(k) number is K810593.

When did NEUROPAC ULTRA I receive FDA 510(k) clearance?

NEUROPAC ULTRA I received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810593.

Who is the listed applicant for NEUROPAC ULTRA I?

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

What is the FDA product code for NEUROPAC ULTRA I?

The FDA product code for NEUROPAC ULTRA I is GZJ.

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Other records listing Medical Devices, Inc. as applicant

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Related Devices (Code: GZJ)

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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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