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FDA 510(k)

CANTATA EMG/EVOKED RESPONSE SYSTEM

K-Number: K896567 · 1990-02-16

ApplicantDantec Medical, Inc.
Decision Date1990-02-16
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CANTATA EMG/EVOKED RESPONSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896567. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANTATA EMG/EVOKED RESPONSE SYSTEM?

CANTATA EMG/EVOKED RESPONSE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K896567.

When did CANTATA EMG/EVOKED RESPONSE SYSTEM receive FDA 510(k) clearance?

CANTATA EMG/EVOKED RESPONSE SYSTEM received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896567.

Who is the listed applicant for CANTATA EMG/EVOKED RESPONSE SYSTEM?

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

What is the FDA product code for CANTATA EMG/EVOKED RESPONSE SYSTEM?

The FDA product code for CANTATA EMG/EVOKED RESPONSE SYSTEM is GWF.

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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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