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FDA 510(k)

PREDICTOR

K-Number: K871436 · 1987-06-19

ApplicantCorazonix Corp.
Decision Date1987-06-19
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREDICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Corazonix Corp.. It received FDA 510(k) clearance on 1987-06-19 under 510(k) number K871436. 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 PREDICTOR?

PREDICTOR is a medical device that received FDA 510(k) clearance on 1987-06-19. The listed applicant is Corazonix Corp.. The 510(k) number is K871436.

When did PREDICTOR receive FDA 510(k) clearance?

PREDICTOR received FDA 510(k) clearance on 1987-06-19, under 510(k) number K871436.

Who is the listed applicant for PREDICTOR?

The FDA 510(k) record lists Corazonix Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREDICTOR?

The FDA product code for PREDICTOR is DQK.

Related Clinical Trials

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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Other records listing Corazonix Corp. 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.

K883855PREDICTOR II SIGNAL AVERAGING ECG

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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