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FDA 510(k)

SUNRAY FETAL MONITOR

K-Number: K123335 · 2013-03-21

ApplicantSunray Medical Apparatus Co., Ltd.
Decision Date2013-03-21
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SUNRAY FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sunray Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K123335. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNRAY FETAL MONITOR?

SUNRAY FETAL MONITOR is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Sunray Medical Apparatus Co., Ltd.. The 510(k) number is K123335.

When did SUNRAY FETAL MONITOR receive FDA 510(k) clearance?

SUNRAY FETAL MONITOR received FDA 510(k) clearance on 2013-03-21, under 510(k) number K123335.

Who is the listed applicant for SUNRAY FETAL MONITOR?

The FDA 510(k) record lists Sunray Medical Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNRAY FETAL MONITOR?

The FDA product code for SUNRAY FETAL MONITOR is HGM.

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Related Devices (Code: HGM)

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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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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