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FDA 510(k)

TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834

K-Number: K040819 · 2004-08-16

ApplicantAmerican I.V. Products, Inc.
Decision Date2004-08-16
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 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 2004-08-16 under 510(k) number K040819. 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 TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834?

TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is American I.V. Products, Inc.. The 510(k) number is K040819.

When did TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 receive FDA 510(k) clearance?

TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 received FDA 510(k) clearance on 2004-08-16, under 510(k) number K040819.

Who is the listed applicant for TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834?

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 TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834?

The FDA product code for TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 is HGM.

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Other records listing American I.V. Products, Inc. as applicant

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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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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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