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FDA 510(k)

CARDIOBEEPER MEMORY MONITOR CB 600 SERIES

K-Number: K894799 · 1989-10-03

ApplicantSurvival Technology, Inc.
Decision Date1989-10-03
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOBEEPER MEMORY MONITOR CB 600 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Survival Technology, Inc.. It received FDA 510(k) clearance on 1989-10-03 under 510(k) number K894799. 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 CARDIOBEEPER MEMORY MONITOR CB 600 SERIES?

CARDIOBEEPER MEMORY MONITOR CB 600 SERIES is a medical device that received FDA 510(k) clearance on 1989-10-03. The listed applicant is Survival Technology, Inc.. The 510(k) number is K894799.

When did CARDIOBEEPER MEMORY MONITOR CB 600 SERIES receive FDA 510(k) clearance?

CARDIOBEEPER MEMORY MONITOR CB 600 SERIES received FDA 510(k) clearance on 1989-10-03, under 510(k) number K894799.

Who is the listed applicant for CARDIOBEEPER MEMORY MONITOR CB 600 SERIES?

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

What is the FDA product code for CARDIOBEEPER MEMORY MONITOR CB 600 SERIES?

The FDA product code for CARDIOBEEPER MEMORY MONITOR CB 600 SERIES is DXH. This falls under the Hematology category.

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Other records listing Survival Technology, 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.

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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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