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FDA 510(k)

AUTOMATED THERAPY SYSTEM

K-Number: K891693 · 1989-08-21

ApplicantHarding & Harris, Inc.
Decision Date1989-08-21
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AUTOMATED THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Harding & Harris, Inc.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K891693. 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 AUTOMATED THERAPY SYSTEM?

AUTOMATED THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Harding & Harris, Inc.. The 510(k) number is K891693.

When did AUTOMATED THERAPY SYSTEM receive FDA 510(k) clearance?

AUTOMATED THERAPY SYSTEM received FDA 510(k) clearance on 1989-08-21, under 510(k) number K891693.

Who is the listed applicant for AUTOMATED THERAPY SYSTEM?

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

What is the FDA product code for AUTOMATED THERAPY SYSTEM?

The FDA product code for AUTOMATED THERAPY SYSTEM is HCC.

Related Clinical Trials

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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

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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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