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FDA 510(k)

CMS SYSTEM

K-Number: K922528 · 1995-05-12

ApplicantMicromedical Industries, Ltd.
Decision Date1995-05-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CMS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Industries, Ltd.. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K922528. 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 CMS SYSTEM?

CMS SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Micromedical Industries, Ltd.. The 510(k) number is K922528.

When did CMS SYSTEM receive FDA 510(k) clearance?

CMS SYSTEM received FDA 510(k) clearance on 1995-05-12, under 510(k) number K922528.

Who is the listed applicant for CMS SYSTEM?

The FDA 510(k) record lists Micromedical Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMS SYSTEM?

The FDA product code for CMS SYSTEM 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 Micromedical Industries, Ltd. 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.

K013311MODIFICATION TO: POCKETVIEW ECG SOFTWAREK012540BLY-501 ADAPTORK990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK915624MODIFIED BIOLOGK915627PACEVIEW

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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