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FDA 510(k)

HEART SENTINEL

K-Number: K802900 · 1981-03-11

ApplicantTotemite Medical Electronics
Decision Date1981-03-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART SENTINEL is the device name listed in this FDA 510(k) record. The listed applicant is Totemite Medical Electronics. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K802900. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART SENTINEL?

HEART SENTINEL is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Totemite Medical Electronics. The 510(k) number is K802900.

When did HEART SENTINEL receive FDA 510(k) clearance?

HEART SENTINEL received FDA 510(k) clearance on 1981-03-11, under 510(k) number K802900.

Who is the listed applicant for HEART SENTINEL?

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

What is the FDA product code for HEART SENTINEL?

The FDA product code for HEART SENTINEL is DSI.

Related Clinical Trials

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Other records listing Totemite Medical Electronics 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.

K872781EASI LEAD SYSTEM CABLE ASSEMBLY

Related Devices (Code: DSI)

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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