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FDA 510(k)

CARDIOBEEPER IV

K-Number: K890461 · 1989-02-23

ApplicantSurvival Technology, Inc.
Decision Date1989-02-23
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOBEEPER IV 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 1989-02-23 under 510(k) number K890461. 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 IV?

CARDIOBEEPER IV is a medical device that received FDA 510(k) clearance on 1989-02-23. The listed applicant is Survival Technology, Inc.. The 510(k) number is K890461.

When did CARDIOBEEPER IV receive FDA 510(k) clearance?

CARDIOBEEPER IV received FDA 510(k) clearance on 1989-02-23, under 510(k) number K890461.

Who is the listed applicant for CARDIOBEEPER IV?

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 IV?

The FDA product code for CARDIOBEEPER IV 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.

K925535CARDIOBEEPER(R) CB-IIAK894799CARDIOBEEPER MEMORY MONITOR CB 600 SERIESK883843CARDIOBEEPER IIK883614CYTOGUARD(R)K880300CARDIOBEEPER(R) IIIK844966CARDIOBEEPER PROFILE MONITOR

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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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