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FDA 510(k)

CARE 5000 CENTRAL MONITOR MS5220 ETC.

K-Number: K842582 · 1984-12-11

ApplicantCare Monitoring Systems
Decision Date1984-12-11
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARE 5000 CENTRAL MONITOR MS5220 ETC. is the device name listed in this FDA 510(k) record. The listed applicant is Care Monitoring Systems. It received FDA 510(k) clearance on 1984-12-11 under 510(k) number K842582. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARE 5000 CENTRAL MONITOR MS5220 ETC.?

CARE 5000 CENTRAL MONITOR MS5220 ETC. is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Care Monitoring Systems. The 510(k) number is K842582.

When did CARE 5000 CENTRAL MONITOR MS5220 ETC. receive FDA 510(k) clearance?

CARE 5000 CENTRAL MONITOR MS5220 ETC. received FDA 510(k) clearance on 1984-12-11, under 510(k) number K842582.

Who is the listed applicant for CARE 5000 CENTRAL MONITOR MS5220 ETC.?

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

What is the FDA product code for CARE 5000 CENTRAL MONITOR MS5220 ETC.?

The FDA product code for CARE 5000 CENTRAL MONITOR MS5220 ETC. is DRT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Care Monitoring Systems 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.

K821015CARE MODEL IP 4500 AUTO SCANNERR

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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