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FDA 510(k)

CARE TELSTAT MODELS: MP 5010 AND MP 5020

K-Number: K874844 · 1988-02-09

ApplicantCare Systems, Inc.
Decision Date1988-02-09
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARE TELSTAT MODELS: MP 5010 AND MP 5020 is the device name listed in this FDA 510(k) record. The listed applicant is Care Systems, Inc.. It received FDA 510(k) clearance on 1988-02-09 under 510(k) number K874844. 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 TELSTAT MODELS: MP 5010 AND MP 5020?

CARE TELSTAT MODELS: MP 5010 AND MP 5020 is a medical device that received FDA 510(k) clearance on 1988-02-09. The listed applicant is Care Systems, Inc.. The 510(k) number is K874844.

When did CARE TELSTAT MODELS: MP 5010 AND MP 5020 receive FDA 510(k) clearance?

CARE TELSTAT MODELS: MP 5010 AND MP 5020 received FDA 510(k) clearance on 1988-02-09, under 510(k) number K874844.

Who is the listed applicant for CARE TELSTAT MODELS: MP 5010 AND MP 5020?

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

What is the FDA product code for CARE TELSTAT MODELS: MP 5010 AND MP 5020?

The FDA product code for CARE TELSTAT MODELS: MP 5010 AND MP 5020 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 Systems, 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.

K910109CARDIOSWISS CM-8K894858CARE 5000 SYSTEM

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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