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FDA 510(k)

CARE MODEL IP 4500 AUTO SCANNERR

K-Number: K821015 · 1982-05-24

ApplicantCare Monitoring Systems
Decision Date1982-05-24
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARE MODEL IP 4500 AUTO SCANNERR 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 1982-05-24 under 510(k) number K821015. 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 MODEL IP 4500 AUTO SCANNERR?

CARE MODEL IP 4500 AUTO SCANNERR is a medical device that received FDA 510(k) clearance on 1982-05-24. The listed applicant is Care Monitoring Systems. The 510(k) number is K821015.

When did CARE MODEL IP 4500 AUTO SCANNERR receive FDA 510(k) clearance?

CARE MODEL IP 4500 AUTO SCANNERR received FDA 510(k) clearance on 1982-05-24, under 510(k) number K821015.

Who is the listed applicant for CARE MODEL IP 4500 AUTO SCANNERR?

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 MODEL IP 4500 AUTO SCANNERR?

The FDA product code for CARE MODEL IP 4500 AUTO SCANNERR 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.

K842582CARE 5000 CENTRAL MONITOR MS5220 ETC.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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