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FDA 510(k)

CARDIAN II CR45A

K-Number: K861621 · 1986-09-12

ApplicantCardiac Recorders, Ltd.
Decision Date1986-09-12
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAN II CR45A 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 1986-09-12 under 510(k) number K861621. 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 CARDIAN II CR45A?

CARDIAN II CR45A is a medical device that received FDA 510(k) clearance on 1986-09-12. The listed applicant is Cardiac Recorders, Ltd.. The 510(k) number is K861621.

When did CARDIAN II CR45A receive FDA 510(k) clearance?

CARDIAN II CR45A received FDA 510(k) clearance on 1986-09-12, under 510(k) number K861621.

Who is the listed applicant for CARDIAN II CR45A?

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 CARDIAN II CR45A?

The FDA product code for CARDIAN II CR45A is DRT.

Related Clinical Trials

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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 CR6AK853673CARDIORATER CR 51K852910CARDIORATER CR7K852887CR5 CARDIAC MONITORK852905CR 280/45, CR281/4 DEFIBRILLATORK852808CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)

View all 8 devices →

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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