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FDA 510(k)

NEUROMEDICS PACETRON HEART RATE MONITOR

K-Number: K823290 · 1982-12-30

ApplicantIntermedics, Inc.
Decision Date1982-12-30
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEUROMEDICS PACETRON HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823290. 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 NEUROMEDICS PACETRON HEART RATE MONITOR?

NEUROMEDICS PACETRON HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Intermedics, Inc.. The 510(k) number is K823290.

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

NEUROMEDICS PACETRON HEART RATE MONITOR received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823290.

Who is the listed applicant for NEUROMEDICS PACETRON HEART RATE MONITOR?

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

What is the FDA product code for NEUROMEDICS PACETRON HEART RATE MONITOR?

The FDA product code for NEUROMEDICS PACETRON HEART RATE MONITOR is DRT.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 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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