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FDA 510(k)

SPACELABS ARRHYTHMIA NET (TM) LEVEL 2

K-Number: K864505 · 1986-11-24

ApplicantSpacelabs, Inc.
Decision Date1986-11-24
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K864505. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS ARRHYTHMIA NET (TM) LEVEL 2?

SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Spacelabs, Inc.. The 510(k) number is K864505.

When did SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 receive FDA 510(k) clearance?

SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 received FDA 510(k) clearance on 1986-11-24, under 510(k) number K864505.

Who is the listed applicant for SPACELABS ARRHYTHMIA NET (TM) LEVEL 2?

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 SPACELABS ARRHYTHMIA NET (TM) LEVEL 2?

The FDA product code for SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 is DSI.

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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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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