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FDA 510(k)

FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS

K-Number: K050826 · 2006-04-10

ApplicantCetro America
Decision Date2006-04-10
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Cetro America. It received FDA 510(k) clearance on 2006-04-10 under 510(k) number K050826. 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 FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS?

FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS is a medical device that received FDA 510(k) clearance on 2006-04-10. The listed applicant is Cetro America. The 510(k) number is K050826.

When did FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS receive FDA 510(k) clearance?

FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS received FDA 510(k) clearance on 2006-04-10, under 510(k) number K050826.

Who is the listed applicant for FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS?

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

What is the FDA product code for FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS?

The FDA product code for FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS is HGM.

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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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