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FDA 510(k)

FEEDBACK EDR SYSTEM MODEL ME-1

K-Number: K792659 · 1980-01-09

ApplicantBio-Feedback Systems, Inc.
Decision Date1980-01-09
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FEEDBACK EDR SYSTEM MODEL ME-1 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Feedback Systems, Inc.. It received FDA 510(k) clearance on 1980-01-09 under 510(k) number K792659. 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 FEEDBACK EDR SYSTEM MODEL ME-1?

FEEDBACK EDR SYSTEM MODEL ME-1 is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is Bio-Feedback Systems, Inc.. The 510(k) number is K792659.

When did FEEDBACK EDR SYSTEM MODEL ME-1 receive FDA 510(k) clearance?

FEEDBACK EDR SYSTEM MODEL ME-1 received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792659.

Who is the listed applicant for FEEDBACK EDR SYSTEM MODEL ME-1?

The FDA 510(k) record lists Bio-Feedback Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEEDBACK EDR SYSTEM MODEL ME-1?

The FDA product code for FEEDBACK EDR SYSTEM MODEL ME-1 is HCC.

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Other records listing Bio-Feedback Systems, Inc. as applicant

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K905372MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002K905373MINIATURE TEMPERATURE TRAINER MODEL DT-002K900063MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)K860914ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONVK832333FEEDBACK EMG SYSTEM PE-020K812619ISOLATED VOLTAGE/FREQUENCY CONVERTER

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Related Devices (Code: HCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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