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FDA 510(k)

HEART-ALERT

K-Number: K820444 · 1982-03-12

ApplicantMedical Equipment Devices, Inc.
Decision Date1982-03-12
Product CodeKHX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEART-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Devices, Inc.. It received FDA 510(k) clearance on 1982-03-12 under 510(k) number K820444. The device is classified under product code KHX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART-ALERT?

HEART-ALERT is a medical device that received FDA 510(k) clearance on 1982-03-12. The listed applicant is Medical Equipment Devices, Inc.. The 510(k) number is K820444.

When did HEART-ALERT receive FDA 510(k) clearance?

HEART-ALERT received FDA 510(k) clearance on 1982-03-12, under 510(k) number K820444.

Who is the listed applicant for HEART-ALERT?

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

What is the FDA product code for HEART-ALERT?

The FDA product code for HEART-ALERT is KHX.

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Related Devices (Code: KHX)

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.

K951771COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPMSms Technologies, Ltd.K946229BALANCE MANAGERNeurocom International, Inc.K942694STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302Biodex Medical Systems, Inc.K930089SMS BALANCE PERFORMANCE MONITORSms Technologies, Ltd.K921340FORCE MEASURING PLATFORMSra Intl., Inc.K901069COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEMComputerized Functional Testing Corp.

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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