FDA 510(k)

NEURO-ECAT

K-Number: K810589 · 1981-04-10

Decision Date1981-04-10

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NEURO-ECAT is the device name listed in this FDA 510(k) record. The listed applicant is Eg&G Ortec, Inc.. It received FDA 510(k) clearance on 1981-04-10 under 510(k) number K810589. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURO-ECAT?

NEURO-ECAT is a medical device that received FDA 510(k) clearance on 1981-04-10. The listed applicant is Eg&G Ortec, Inc.. The 510(k) number is K810589.

When did NEURO-ECAT receive FDA 510(k) clearance?

NEURO-ECAT received FDA 510(k) clearance on 1981-04-10, under 510(k) number K810589.

Who is the listed applicant for NEURO-ECAT?

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

What is the FDA product code for NEURO-ECAT?

The FDA product code for NEURO-ECAT is KPS.

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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.