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FDA 510(k)

CR5 CARDIAC MONITOR

K-Number: K852887 · 1985-11-14

ApplicantCardiac Recorders, Ltd.
Decision Date1985-11-14
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CR5 CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Recorders, Ltd.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K852887. 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 CR5 CARDIAC MONITOR?

CR5 CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Cardiac Recorders, Ltd.. The 510(k) number is K852887.

When did CR5 CARDIAC MONITOR receive FDA 510(k) clearance?

CR5 CARDIAC MONITOR received FDA 510(k) clearance on 1985-11-14, under 510(k) number K852887.

Who is the listed applicant for CR5 CARDIAC MONITOR?

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

What is the FDA product code for CR5 CARDIAC MONITOR?

The FDA product code for CR5 CARDIAC MONITOR is DRT.

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Other records listing Cardiac Recorders, 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.

K864704CARDIAN III CR6AK861621CARDIAN II CR45AK853673CARDIORATER CR 51K852910CARDIORATER CR7K852905CR 280/45, CR281/4 DEFIBRILLATORK8527992006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)

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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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