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FDA 510(k)

REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

K-Number: K000443 · 2000-04-24

ApplicantR4 Telemedicine, Inc.
Decision Date2000-04-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REMOTE FETAL MEDICINE ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is R4 Telemedicine, Inc.. It received FDA 510(k) clearance on 2000-04-24 under 510(k) number K000443. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE FETAL MEDICINE ULTRASOUND SYSTEM?

REMOTE FETAL MEDICINE ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2000-04-24. The listed applicant is R4 Telemedicine, Inc.. The 510(k) number is K000443.

When did REMOTE FETAL MEDICINE ULTRASOUND SYSTEM receive FDA 510(k) clearance?

REMOTE FETAL MEDICINE ULTRASOUND SYSTEM received FDA 510(k) clearance on 2000-04-24, under 510(k) number K000443.

Who is the listed applicant for REMOTE FETAL MEDICINE ULTRASOUND SYSTEM?

The FDA 510(k) record lists R4 Telemedicine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMOTE FETAL MEDICINE ULTRASOUND SYSTEM?

The FDA product code for REMOTE FETAL MEDICINE ULTRASOUND SYSTEM is LLZ.

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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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