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FDA 510(k)

LME HEART-RATE MONITOR

K-Number: K832016 · 1983-10-26

ApplicantLitton Medical Electronics
Decision Date1983-10-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LME HEART-RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Litton Medical Electronics. It received FDA 510(k) clearance on 1983-10-26 under 510(k) number K832016. 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 LME HEART-RATE MONITOR?

LME HEART-RATE MONITOR is a medical device that received FDA 510(k) clearance on 1983-10-26. The listed applicant is Litton Medical Electronics. The 510(k) number is K832016.

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

LME HEART-RATE MONITOR received FDA 510(k) clearance on 1983-10-26, under 510(k) number K832016.

Who is the listed applicant for LME HEART-RATE MONITOR?

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

What is the FDA product code for LME HEART-RATE MONITOR?

The FDA product code for LME HEART-RATE MONITOR is DRT.

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Other records listing Litton Medical Electronics 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.

K840522RECOMED BLOOD-FLOW METER H236-052-02K840899SERVOMED ARRHYCOMP CENTRAL MONITOR SYSK840439RECOMED CARDIAC OUTPUT METER 236067-K840523SERVOMED PULSE AMPLIFIER MODULE-206-K840524SERVOMED BASIC BEDSIDE UNIT SMV 110TPK840209SERVOMED MEDIVISION SCOPE SMV-235

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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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