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FDA 510(k)

THE CRITERION II PACING SYS. MONITOR

K-Number: K802782 · 1980-11-19

ApplicantDart Medical Equipment
Decision Date1980-11-19
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CRITERION II PACING SYS. MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Dart Medical Equipment. It received FDA 510(k) clearance on 1980-11-19 under 510(k) number K802782. 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 THE CRITERION II PACING SYS. MONITOR?

THE CRITERION II PACING SYS. MONITOR is a medical device that received FDA 510(k) clearance on 1980-11-19. The listed applicant is Dart Medical Equipment. The 510(k) number is K802782.

When did THE CRITERION II PACING SYS. MONITOR receive FDA 510(k) clearance?

THE CRITERION II PACING SYS. MONITOR received FDA 510(k) clearance on 1980-11-19, under 510(k) number K802782.

Who is the listed applicant for THE CRITERION II PACING SYS. MONITOR?

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

What is the FDA product code for THE CRITERION II PACING SYS. MONITOR?

The FDA product code for THE CRITERION II PACING SYS. MONITOR is DRT.

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Other records listing Dart Medical Equipment 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.

K820986EKG MONITORS, VARIOUS MODELSK820904EKG TELEPHONE CONVERTERK820828SAMMK803315CRITERION II RHYTHM PROFILE MONITORK802325CRITERION II PACING SYSTEM MONITORSK800286CRITERION II PACING SYSTEM MONITORS

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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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