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FDA 510(k)

CRITICALC

K-Number: K860854 · 1986-12-08

ApplicantCygnus of South Florida, Inc.
Decision Date1986-12-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITICALC is the device name listed in this FDA 510(k) record. The listed applicant is Cygnus of South Florida, Inc.. It received FDA 510(k) clearance on 1986-12-08 under 510(k) number K860854. 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 CRITICALC?

CRITICALC is a medical device that received FDA 510(k) clearance on 1986-12-08. The listed applicant is Cygnus of South Florida, Inc.. The 510(k) number is K860854.

When did CRITICALC receive FDA 510(k) clearance?

CRITICALC received FDA 510(k) clearance on 1986-12-08, under 510(k) number K860854.

Who is the listed applicant for CRITICALC?

The FDA 510(k) record lists Cygnus of South Florida, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRITICALC?

The FDA product code for CRITICALC 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 Cygnus of South Florida, 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.

K854265SIMULATOR

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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