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FDA 510(k)

PROFESSIONAL MARK I BIOFEEDBACK SYS

K-Number: K823381 · 1983-01-05

ApplicantSrs Co.
Decision Date1983-01-05
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROFESSIONAL MARK I BIOFEEDBACK SYS is the device name listed in this FDA 510(k) record. The listed applicant is Srs Co.. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K823381. 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 PROFESSIONAL MARK I BIOFEEDBACK SYS?

PROFESSIONAL MARK I BIOFEEDBACK SYS is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Srs Co.. The 510(k) number is K823381.

When did PROFESSIONAL MARK I BIOFEEDBACK SYS receive FDA 510(k) clearance?

PROFESSIONAL MARK I BIOFEEDBACK SYS received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823381.

Who is the listed applicant for PROFESSIONAL MARK I BIOFEEDBACK SYS?

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

What is the FDA product code for PROFESSIONAL MARK I BIOFEEDBACK SYS?

The FDA product code for PROFESSIONAL MARK I BIOFEEDBACK SYS is HCC.

Related Clinical Trials

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.

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Other records listing Srs Co. as applicant

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.

K813510CARDIOSONIC ACOUSTIC AMPLIFIER

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

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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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