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FDA 510(k)

TELEMETRY PACEMAKER MONITOR

K-Number: K802357 · 1981-02-12

ApplicantIntermedics, Inc.
Decision Date1981-02-12
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEMETRY PACEMAKER 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 1981-02-12 under 510(k) number K802357. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELEMETRY PACEMAKER MONITOR?

TELEMETRY PACEMAKER MONITOR is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Intermedics, Inc.. The 510(k) number is K802357.

When did TELEMETRY PACEMAKER MONITOR receive FDA 510(k) clearance?

TELEMETRY PACEMAKER MONITOR received FDA 510(k) clearance on 1981-02-12, under 510(k) number K802357.

Who is the listed applicant for TELEMETRY PACEMAKER 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 TELEMETRY PACEMAKER MONITOR?

The FDA product code for TELEMETRY PACEMAKER MONITOR is DRG.

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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

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Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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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