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FDA 510(k)

CARDIOTEST 2200

K-Number: K790503 · 1979-05-17

ApplicantCardiac Pacemakers, Inc.
Decision Date1979-05-17
Product CodeDTA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTEST 2200 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1979-05-17 under 510(k) number K790503. The device is classified under product code DTA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTEST 2200?

CARDIOTEST 2200 is a medical device that received FDA 510(k) clearance on 1979-05-17. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K790503.

When did CARDIOTEST 2200 receive FDA 510(k) clearance?

CARDIOTEST 2200 received FDA 510(k) clearance on 1979-05-17, under 510(k) number K790503.

Who is the listed applicant for CARDIOTEST 2200?

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

What is the FDA product code for CARDIOTEST 2200?

The FDA product code for CARDIOTEST 2200 is DTA.

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Other records listing Cardiac Pacemakers, Inc. as applicant

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Related Devices (Code: DTA)

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.

K163008CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc.K101982MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180St Jude Medical, CrmdK073230MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERSBiotronik, Inc.K050884ADAPTER CABLERemington Medical, Inc.K033613MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.K022360ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.Biotronik, Inc.

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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