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FDA 510(k)

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +

K-Number: K061780 · 2006-09-15

ApplicantRozinn Electronics, Inc.
Decision Date2006-09-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + is the device name listed in this FDA 510(k) record. The listed applicant is Rozinn Electronics, Inc.. It received FDA 510(k) clearance on 2006-09-15 under 510(k) number K061780. 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 TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +?

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is Rozinn Electronics, Inc.. The 510(k) number is K061780.

When did TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + receive FDA 510(k) clearance?

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + received FDA 510(k) clearance on 2006-09-15, under 510(k) number K061780.

Who is the listed applicant for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +?

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

What is the FDA product code for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +?

The FDA product code for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + is DXH. This falls under the Hematology category.

Related Clinical Trials

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Other records listing Rozinn Electronics, Inc. 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.

K042463HOLTER PLUSK022540CARDIO ID+(RZ153+)K021517ABP FOR WINDOWSK020213NETLINK/NETSCANK903331ROZINN 151

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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