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FDA 510(k)

HEARTRATE PLUS ECG CARDULE #1918

K-Number: K830306 · 1983-03-17

ApplicantSpacelabs, Inc.
Decision Date1983-03-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTRATE PLUS ECG CARDULE #1918 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830306. 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 HEARTRATE PLUS ECG CARDULE #1918?

HEARTRATE PLUS ECG CARDULE #1918 is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Spacelabs, Inc.. The 510(k) number is K830306.

When did HEARTRATE PLUS ECG CARDULE #1918 receive FDA 510(k) clearance?

HEARTRATE PLUS ECG CARDULE #1918 received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830306.

Who is the listed applicant for HEARTRATE PLUS ECG CARDULE #1918?

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 HEARTRATE PLUS ECG CARDULE #1918?

The FDA product code for HEARTRATE PLUS ECG CARDULE #1918 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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