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FDA 510(k)

P.H.D. - PERSONAL HEART DEVICE MODEL 5258

K-Number: K963904 · 1997-05-15

ApplicantHeart Alert, Inc.
Decision Date1997-05-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

P.H.D. - PERSONAL HEART DEVICE MODEL 5258 is the device name listed in this FDA 510(k) record. The listed applicant is Heart Alert, Inc.. It received FDA 510(k) clearance on 1997-05-15 under 510(k) number K963904. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.H.D. - PERSONAL HEART DEVICE MODEL 5258?

P.H.D. - PERSONAL HEART DEVICE MODEL 5258 is a medical device that received FDA 510(k) clearance on 1997-05-15. The listed applicant is Heart Alert, Inc.. The 510(k) number is K963904.

When did P.H.D. - PERSONAL HEART DEVICE MODEL 5258 receive FDA 510(k) clearance?

P.H.D. - PERSONAL HEART DEVICE MODEL 5258 received FDA 510(k) clearance on 1997-05-15, under 510(k) number K963904.

Who is the listed applicant for P.H.D. - PERSONAL HEART DEVICE MODEL 5258?

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

What is the FDA product code for P.H.D. - PERSONAL HEART DEVICE MODEL 5258?

The FDA product code for P.H.D. - PERSONAL HEART DEVICE MODEL 5258 is DXH. This falls under the Hematology category.

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Related Devices (Code: DXH)

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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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