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FDA 510(k)

HTS 220 CARDIAC MONITOR

K-Number: K884524 · 1989-04-10

ApplicantLife Sensing Instrument Company, Inc.
Decision Date1989-04-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HTS 220 CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Life Sensing Instrument Company, Inc.. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K884524. 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 HTS 220 CARDIAC MONITOR?

HTS 220 CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Life Sensing Instrument Company, Inc.. The 510(k) number is K884524.

When did HTS 220 CARDIAC MONITOR receive FDA 510(k) clearance?

HTS 220 CARDIAC MONITOR received FDA 510(k) clearance on 1989-04-10, under 510(k) number K884524.

Who is the listed applicant for HTS 220 CARDIAC MONITOR?

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

What is the FDA product code for HTS 220 CARDIAC MONITOR?

The FDA product code for HTS 220 CARDIAC MONITOR is DSI.

Related Clinical Trials

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Other records listing Life Sensing Instrument Company, 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.

K960884TELE TRENS TM 10K931136APOLLO CAMERAK896967HTS 820 CARDIAC MONITORK861067PARAGON 420, CARDIAC MONITOR

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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