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FDA 510(k)

ORION BIOFEEDBACK DATA ACQUISITION

K-Number: K840223 · 1984-03-09

ApplicantSelf Regulation Systems, Inc.
Decision Date1984-03-09
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORION BIOFEEDBACK DATA ACQUISITION is the device name listed in this FDA 510(k) record. The listed applicant is Self Regulation Systems, Inc.. It received FDA 510(k) clearance on 1984-03-09 under 510(k) number K840223. 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 ORION BIOFEEDBACK DATA ACQUISITION?

ORION BIOFEEDBACK DATA ACQUISITION is a medical device that received FDA 510(k) clearance on 1984-03-09. The listed applicant is Self Regulation Systems, Inc.. The 510(k) number is K840223.

When did ORION BIOFEEDBACK DATA ACQUISITION receive FDA 510(k) clearance?

ORION BIOFEEDBACK DATA ACQUISITION received FDA 510(k) clearance on 1984-03-09, under 510(k) number K840223.

Who is the listed applicant for ORION BIOFEEDBACK DATA ACQUISITION?

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

What is the FDA product code for ORION BIOFEEDBACK DATA ACQUISITION?

The FDA product code for ORION BIOFEEDBACK DATA ACQUISITION is HCC.

Related Clinical Trials

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Other records listing Self Regulation Systems, Inc. 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.

K875308PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421K870793SELF REGULATION SYS PROF SERIES BIOFEEDBACK DEVICE

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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