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FDA 510(k)

RT5000 ECHOCARDIOGRAPHY #H4100C/CE

K-Number: K870726 · 1987-10-20

ApplicantGeneral Electric Co.
Decision Date1987-10-20
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RT5000 ECHOCARDIOGRAPHY #H4100C/CE is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K870726. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT5000 ECHOCARDIOGRAPHY #H4100C/CE?

RT5000 ECHOCARDIOGRAPHY #H4100C/CE is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is General Electric Co.. The 510(k) number is K870726.

When did RT5000 ECHOCARDIOGRAPHY #H4100C/CE receive FDA 510(k) clearance?

RT5000 ECHOCARDIOGRAPHY #H4100C/CE received FDA 510(k) clearance on 1987-10-20, under 510(k) number K870726.

Who is the listed applicant for RT5000 ECHOCARDIOGRAPHY #H4100C/CE?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT5000 ECHOCARDIOGRAPHY #H4100C/CE?

The FDA product code for RT5000 ECHOCARDIOGRAPHY #H4100C/CE is JOP.

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Other records listing General Electric Co. as applicant

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Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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