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FDA 510(k)

ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE

K-Number: K980373 · 1998-04-29

ApplicantUltramind International , Ltd.
Decision Date1998-04-29
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Ultramind International , Ltd.. It received FDA 510(k) clearance on 1998-04-29 under 510(k) number K980373. 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 ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE?

ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE is a medical device that received FDA 510(k) clearance on 1998-04-29. The listed applicant is Ultramind International , Ltd.. The 510(k) number is K980373.

When did ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE receive FDA 510(k) clearance?

ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE received FDA 510(k) clearance on 1998-04-29, under 510(k) number K980373.

Who is the listed applicant for ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE?

The FDA 510(k) record lists Ultramind International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE?

The FDA product code for ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE is HCC.

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Other records listing Ultramind International , Ltd. 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.

K951213RELAXPLUS

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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