FDA 510(k)

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

K-Number: K040392 · 2004-09-14

Decision Date2004-09-14

Product CodeHFM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is American I.V. Products, Inc.. It received FDA 510(k) clearance on 2004-09-14 under 510(k) number K040392. The device is classified under product code HFM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING?

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING is a medical device that received FDA 510(k) clearance on 2004-09-14. The listed applicant is American I.V. Products, Inc.. The 510(k) number is K040392.

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

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING received FDA 510(k) clearance on 2004-09-14, under 510(k) number K040392.

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

The FDA 510(k) record lists American I.V. Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING is HFM.

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Related Devices (Code: HFM)

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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.