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FDA 510(k)

HEARTWATCH

K-Number: K800519 · 1980-09-26

ApplicantD. Jenkins
Decision Date1980-09-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTWATCH is the device name listed in this FDA 510(k) record. The listed applicant is D. Jenkins. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K800519. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTWATCH?

HEARTWATCH is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is D. Jenkins. The 510(k) number is K800519.

When did HEARTWATCH receive FDA 510(k) clearance?

HEARTWATCH received FDA 510(k) clearance on 1980-09-26, under 510(k) number K800519.

Who is the listed applicant for HEARTWATCH?

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

What is the FDA product code for HEARTWATCH?

The FDA product code for HEARTWATCH is DRT.

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Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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