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FDA 510(k)

MODEL TT-185 TELEMETRY TRANSMITTER

K-Number: K851624 · 1986-01-14

ApplicantEaton Medical Group
Decision Date1986-01-14
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL TT-185 TELEMETRY TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Eaton Medical Group. It received FDA 510(k) clearance on 1986-01-14 under 510(k) number K851624. 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 MODEL TT-185 TELEMETRY TRANSMITTER?

MODEL TT-185 TELEMETRY TRANSMITTER is a medical device that received FDA 510(k) clearance on 1986-01-14. The listed applicant is Eaton Medical Group. The 510(k) number is K851624.

When did MODEL TT-185 TELEMETRY TRANSMITTER receive FDA 510(k) clearance?

MODEL TT-185 TELEMETRY TRANSMITTER received FDA 510(k) clearance on 1986-01-14, under 510(k) number K851624.

Who is the listed applicant for MODEL TT-185 TELEMETRY TRANSMITTER?

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

What is the FDA product code for MODEL TT-185 TELEMETRY TRANSMITTER?

The FDA product code for MODEL TT-185 TELEMETRY TRANSMITTER is DXH. This falls under the Hematology category.

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Other records listing Eaton Medical Group as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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