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FDA 510(k)

HEART RATE COMPUTER

K-Number: K791862 · 1979-10-04

ApplicantStanford Assoc., Inc.
Decision Date1979-10-04
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART RATE COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Stanford Assoc., Inc.. It received FDA 510(k) clearance on 1979-10-04 under 510(k) number K791862. 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 HEART RATE COMPUTER?

HEART RATE COMPUTER is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Stanford Assoc., Inc.. The 510(k) number is K791862.

When did HEART RATE COMPUTER receive FDA 510(k) clearance?

HEART RATE COMPUTER received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791862.

Who is the listed applicant for HEART RATE COMPUTER?

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

What is the FDA product code for HEART RATE COMPUTER?

The FDA product code for HEART RATE COMPUTER is DRT.

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 Stanford Assoc., 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.

K791927HEART RATE COMPUTER STRIP CHART

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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