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FDA 510(k)

AMBULATORY EEG PLAYBACK

K-Number: K872183 · 1987-07-21

ApplicantCadwell Laboratories, Inc.
Decision Date1987-07-21
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMBULATORY EEG PLAYBACK is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872183. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY EEG PLAYBACK?

AMBULATORY EEG PLAYBACK is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K872183.

When did AMBULATORY EEG PLAYBACK receive FDA 510(k) clearance?

AMBULATORY EEG PLAYBACK received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872183.

Who is the listed applicant for AMBULATORY EEG PLAYBACK?

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

What is the FDA product code for AMBULATORY EEG PLAYBACK?

The FDA product code for AMBULATORY EEG PLAYBACK is GWQ.

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Other records listing Cadwell Laboratories, Inc. as applicant

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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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