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FDA 510(k)

RECORD KEEPING/DATA MANAGEMENT SYSTEM

K-Number: K865035 · 1987-05-11

ApplicantCritical Care Systems, Inc.
Decision Date1987-05-11
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RECORD KEEPING/DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Critical Care Systems, Inc.. It received FDA 510(k) clearance on 1987-05-11 under 510(k) number K865035. 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 RECORD KEEPING/DATA MANAGEMENT SYSTEM?

RECORD KEEPING/DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1987-05-11. The listed applicant is Critical Care Systems, Inc.. The 510(k) number is K865035.

When did RECORD KEEPING/DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

RECORD KEEPING/DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 1987-05-11, under 510(k) number K865035.

Who is the listed applicant for RECORD KEEPING/DATA MANAGEMENT SYSTEM?

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

What is the FDA product code for RECORD KEEPING/DATA MANAGEMENT SYSTEM?

The FDA product code for RECORD KEEPING/DATA MANAGEMENT SYSTEM 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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