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FDA 510(k)

CARDIAC ACQUISITION SYSTEM, ICR 2001

K-Number: K770705 · 1977-06-02

ApplicantInstruments For Cardiac Research
Decision Date1977-06-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC ACQUISITION SYSTEM, ICR 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Instruments For Cardiac Research. It received FDA 510(k) clearance on 1977-06-02 under 510(k) number K770705. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC ACQUISITION SYSTEM, ICR 2001?

CARDIAC ACQUISITION SYSTEM, ICR 2001 is a medical device that received FDA 510(k) clearance on 1977-06-02. The listed applicant is Instruments For Cardiac Research. The 510(k) number is K770705.

When did CARDIAC ACQUISITION SYSTEM, ICR 2001 receive FDA 510(k) clearance?

CARDIAC ACQUISITION SYSTEM, ICR 2001 received FDA 510(k) clearance on 1977-06-02, under 510(k) number K770705.

Who is the listed applicant for CARDIAC ACQUISITION SYSTEM, ICR 2001?

The FDA 510(k) record lists Instruments For Cardiac Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC ACQUISITION SYSTEM, ICR 2001?

The FDA product code for CARDIAC ACQUISITION SYSTEM, ICR 2001 is DQK.

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Other records listing Instruments For Cardiac Research 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.

K834397HOLTER CARDIOGRAPHY SYS 6201K821173EVENTMASTER 3 HOLTER EVENT SCANNERK820856EVENTMASTER 2K820011CARDIOSTRESSK812920EVENT MASTERK801903SERIES 4000 STRESS & EXERCISE SYSTEM

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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