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FDA 510(k)

BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)

K-Number: K022596 · 2003-01-31

ApplicantClover Hi-Tech, Inc.
Decision Date2003-01-31
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) is the device name listed in this FDA 510(k) record. The listed applicant is Clover Hi-Tech, Inc.. It received FDA 510(k) clearance on 2003-01-31 under 510(k) number K022596. 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 BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)?

BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) is a medical device that received FDA 510(k) clearance on 2003-01-31. The listed applicant is Clover Hi-Tech, Inc.. The 510(k) number is K022596.

When did BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) receive FDA 510(k) clearance?

BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) received FDA 510(k) clearance on 2003-01-31, under 510(k) number K022596.

Who is the listed applicant for BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)?

The FDA 510(k) record lists Clover Hi-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)?

The FDA product code for BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) is DQK.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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