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FDA 510(k)

PACEMAKER PATIENT MGMT. SYSTEM

K-Number: K801810 · 1981-02-05

ApplicantSiemens Elema AB
Decision Date1981-02-05
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER PATIENT MGMT. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1981-02-05 under 510(k) number K801810. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACEMAKER PATIENT MGMT. SYSTEM?

PACEMAKER PATIENT MGMT. SYSTEM is a medical device that received FDA 510(k) clearance on 1981-02-05. The listed applicant is Siemens Elema AB. The 510(k) number is K801810.

When did PACEMAKER PATIENT MGMT. SYSTEM receive FDA 510(k) clearance?

PACEMAKER PATIENT MGMT. SYSTEM received FDA 510(k) clearance on 1981-02-05, under 510(k) number K801810.

Who is the listed applicant for PACEMAKER PATIENT MGMT. SYSTEM?

The FDA 510(k) record lists Siemens Elema AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACEMAKER PATIENT MGMT. SYSTEM?

The FDA product code for PACEMAKER PATIENT MGMT. SYSTEM is DQK.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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