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FDA 510(k)

ARRHYTHMIA III CARDULE #1919

K-Number: K832693 · 1983-11-07

ApplicantSpacelabs, Inc.
Decision Date1983-11-07
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRHYTHMIA III CARDULE #1919 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K832693. 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 ARRHYTHMIA III CARDULE #1919?

ARRHYTHMIA III CARDULE #1919 is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Spacelabs, Inc.. The 510(k) number is K832693.

When did ARRHYTHMIA III CARDULE #1919 receive FDA 510(k) clearance?

ARRHYTHMIA III CARDULE #1919 received FDA 510(k) clearance on 1983-11-07, under 510(k) number K832693.

Who is the listed applicant for ARRHYTHMIA III CARDULE #1919?

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 III CARDULE #1919?

The FDA product code for ARRHYTHMIA III CARDULE #1919 is DSI.

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Other records listing Spacelabs, Inc. as applicant

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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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