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FDA 510(k)

ARRHYTHMIA II EDITOR

K-Number: K791776 · 1979-10-02

ApplicantSpacelabs, Inc.
Decision Date1979-10-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRHYTHMIA II EDITOR is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1979-10-02 under 510(k) number K791776. 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 ARRHYTHMIA II EDITOR?

ARRHYTHMIA II EDITOR is a medical device that received FDA 510(k) clearance on 1979-10-02. The listed applicant is Spacelabs, Inc.. The 510(k) number is K791776.

When did ARRHYTHMIA II EDITOR receive FDA 510(k) clearance?

ARRHYTHMIA II EDITOR received FDA 510(k) clearance on 1979-10-02, under 510(k) number K791776.

Who is the listed applicant for ARRHYTHMIA II EDITOR?

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

What is the FDA product code for ARRHYTHMIA II EDITOR?

The FDA product code for ARRHYTHMIA II EDITOR is DQK.

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Other records listing Spacelabs, 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.

K954962SPACELABS MEDICAL MULTIGAS ANALYZERK951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

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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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