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FDA 510(k)

RE1000 HEART RATE MONITOR

K-Number: K822319 · 1982-09-14

ApplicantElectronic Monitors, Inc.
Decision Date1982-09-14
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RE1000 HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Monitors, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822319. 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 RE1000 HEART RATE MONITOR?

RE1000 HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Electronic Monitors, Inc.. The 510(k) number is K822319.

When did RE1000 HEART RATE MONITOR receive FDA 510(k) clearance?

RE1000 HEART RATE MONITOR received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822319.

Who is the listed applicant for RE1000 HEART RATE MONITOR?

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

What is the FDA product code for RE1000 HEART RATE MONITOR?

The FDA product code for RE1000 HEART RATE MONITOR 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 Electronic Monitors, 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.

K922393EMITENS ELECTRODESK842696LIFE-MASK INFANT RESUSCITATOR

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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