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FDA 510(k)

CARDIAC EVENT RECORDER

K-Number: K843533 · 1985-06-28

ApplicantCryo2 Corp.
Decision Date1985-06-28
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Cryo2 Corp.. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K843533. 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 CARDIAC EVENT RECORDER?

CARDIAC EVENT RECORDER is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Cryo2 Corp.. The 510(k) number is K843533.

When did CARDIAC EVENT RECORDER receive FDA 510(k) clearance?

CARDIAC EVENT RECORDER received FDA 510(k) clearance on 1985-06-28, under 510(k) number K843533.

Who is the listed applicant for CARDIAC EVENT RECORDER?

The FDA 510(k) record lists Cryo2 Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC EVENT RECORDER?

The FDA product code for CARDIAC EVENT RECORDER 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.

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Other records listing Cryo2 Corp. 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.

K841893MAXAMAN

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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