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FDA 510(k)

THE EXPERT MODELS RTS 2000 AND RTS 2000H

K-Number: K862947 · 1987-11-04

ApplicantOcg Technology, Inc.
Decision Date1987-11-04
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE EXPERT MODELS RTS 2000 AND RTS 2000H is the device name listed in this FDA 510(k) record. The listed applicant is Ocg Technology, Inc.. It received FDA 510(k) clearance on 1987-11-04 under 510(k) number K862947. 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 THE EXPERT MODELS RTS 2000 AND RTS 2000H?

THE EXPERT MODELS RTS 2000 AND RTS 2000H is a medical device that received FDA 510(k) clearance on 1987-11-04. The listed applicant is Ocg Technology, Inc.. The 510(k) number is K862947.

When did THE EXPERT MODELS RTS 2000 AND RTS 2000H receive FDA 510(k) clearance?

THE EXPERT MODELS RTS 2000 AND RTS 2000H received FDA 510(k) clearance on 1987-11-04, under 510(k) number K862947.

Who is the listed applicant for THE EXPERT MODELS RTS 2000 AND RTS 2000H?

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

What is the FDA product code for THE EXPERT MODELS RTS 2000 AND RTS 2000H?

The FDA product code for THE EXPERT MODELS RTS 2000 AND RTS 2000H is DSI.

Related Clinical Trials

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.

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Other records listing Ocg Technology, 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.

K863153MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPHK812971CARDIOINTEGRAM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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