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FDA 510(k)

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS

K-Number: K844391 · 1985-01-07

ApplicantAms Medical, Inc.
Decision Date1985-01-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS is the device name listed in this FDA 510(k) record. The listed applicant is Ams Medical, Inc.. It received FDA 510(k) clearance on 1985-01-07 under 510(k) number K844391. 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 NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS?

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is Ams Medical, Inc.. The 510(k) number is K844391.

When did NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS receive FDA 510(k) clearance?

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS received FDA 510(k) clearance on 1985-01-07, under 510(k) number K844391.

Who is the listed applicant for NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS?

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

What is the FDA product code for NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS?

The FDA product code for NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS is DXH. This falls under the Hematology category.

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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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