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FDA 510(k)

TELEREHAB SYSTEM FOR CARDIAC REHABILITATION

K-Number: K895719 · 1990-03-06

ApplicantScottcare Corp.
Decision Date1990-03-06
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEREHAB SYSTEM FOR CARDIAC REHABILITATION is the device name listed in this FDA 510(k) record. The listed applicant is Scottcare Corp.. It received FDA 510(k) clearance on 1990-03-06 under 510(k) number K895719. 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 TELEREHAB SYSTEM FOR CARDIAC REHABILITATION?

TELEREHAB SYSTEM FOR CARDIAC REHABILITATION is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Scottcare Corp.. The 510(k) number is K895719.

When did TELEREHAB SYSTEM FOR CARDIAC REHABILITATION receive FDA 510(k) clearance?

TELEREHAB SYSTEM FOR CARDIAC REHABILITATION received FDA 510(k) clearance on 1990-03-06, under 510(k) number K895719.

Who is the listed applicant for TELEREHAB SYSTEM FOR CARDIAC REHABILITATION?

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

What is the FDA product code for TELEREHAB SYSTEM FOR CARDIAC REHABILITATION?

The FDA product code for TELEREHAB SYSTEM FOR CARDIAC REHABILITATION is DXH. This falls under the Hematology category.

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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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