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FDA 510(k)

HPM 40 HEART PACEMAKER MONITOR

K-Number: K922742 · 1993-03-18

ApplicantBiotronik, GmbH & Co.
Decision Date1993-03-18
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HPM 40 HEART PACEMAKER MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K922742. The device is classified under product code KRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPM 40 HEART PACEMAKER MONITOR?

HPM 40 HEART PACEMAKER MONITOR is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K922742.

When did HPM 40 HEART PACEMAKER MONITOR receive FDA 510(k) clearance?

HPM 40 HEART PACEMAKER MONITOR received FDA 510(k) clearance on 1993-03-18, under 510(k) number K922742.

Who is the listed applicant for HPM 40 HEART PACEMAKER MONITOR?

The FDA 510(k) record lists Biotronik, GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HPM 40 HEART PACEMAKER MONITOR?

The FDA product code for HPM 40 HEART PACEMAKER MONITOR is KRE.

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Other records listing Biotronik, GmbH & Co. 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.

K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051K923406BIOSCOPEK923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERK914109PIKOS 01 & PIKOS E 01K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIPK911142LEAD TERMINAL PIN CAPS, VARIOUS MODELS

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Related Devices (Code: KRE)

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.

K110693PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.K072950CYGNUS 12 LEAD ECG MODULECygnus, LLCK032926EKG SPEAKSMedtronic VascularK915632PACEART CPTS-86/12Paceart, Inc.K895535PACEVIEWMicromedicalK870909PACEMAKER FUNCTION ANALYZERPaceart, 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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