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FDA 510(k)

BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH

K-Number: K894510 · 1990-01-16

ApplicantCapscan Corp.
Decision Date1990-01-16
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Capscan Corp.. It received FDA 510(k) clearance on 1990-01-16 under 510(k) number K894510. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH?

BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH is a medical device that received FDA 510(k) clearance on 1990-01-16. The listed applicant is Capscan Corp.. The 510(k) number is K894510.

When did BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH receive FDA 510(k) clearance?

BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH received FDA 510(k) clearance on 1990-01-16, under 510(k) number K894510.

Who is the listed applicant for BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH?

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

What is the FDA product code for BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH?

The FDA product code for BIOFEEDBACK ELECTROENCEPHALOGRAPH/ELECTROMYOGRAPH is HCC.

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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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