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FDA 510(k)

RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER

K-Number: K063609 · 2007-09-12

ApplicantShl Telemedicine International , Ltd.
Decision Date2007-09-12
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Shl Telemedicine International , Ltd.. It received FDA 510(k) clearance on 2007-09-12 under 510(k) number K063609. 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 RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER?

RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER is a medical device that received FDA 510(k) clearance on 2007-09-12. The listed applicant is Shl Telemedicine International , Ltd.. The 510(k) number is K063609.

When did RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER receive FDA 510(k) clearance?

RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER received FDA 510(k) clearance on 2007-09-12, under 510(k) number K063609.

Who is the listed applicant for RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER?

The FDA 510(k) record lists Shl Telemedicine International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER?

The FDA product code for RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER is DXH. This falls under the Hematology category.

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Other records listing Shl Telemedicine International , Ltd. as applicant

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Related Devices (Code: DXH)

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Official Source

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