Fetal Monitor, Part #100-11009

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K770297 ↗

FDA Product Code

HGM

Device Class

Class II

Regulation

21 CFR Part 884.2740

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Phipiological Synchronizer Part#205

  Class II

  FDA 510(k) K781681 Active Cleared 17 Oct 1978

• Synchronizer #208

  Class I

  FDA 510(k) K810588 Active Cleared 10 Apr 1981

• Transcutaneous Blood Oxygen Monitor #300

  Class II

  FDA 510(k) K802978 Active Cleared 2 Feb 1981

• Monitor, Fetal, No. L04-1100

  Class II

  FDA 510(k) K770692 Active Cleared 26 Apr 1977

• Abdominal ECG Processor for Fetal Moni.

  Class II

  FDA 510(k) K770295 Active Cleared 9 Mar 1977

• Fetal Monitor, Part #101-11009

  Class II

  FDA 510(k) K770296 Active Cleared 9 Mar 1977

• What is the Brattle Fetal Monitor, Part #100-11009 used for?

  The Brattle Fetal Monitor, Part #100-11009 is designed to graphically display the relationship between maternal uterine contractions and fetal heart rate. This allows clinicians to visually assess fetal well-being in real-time during pregnancy, labor, and delivery. By integrating both uterine contraction and fetal heart monitoring, it provides a comprehensive view to support obstetric decision-making.

• How is the Brattle Fetal Monitor, Part #100-11009 supplied and intended for use?

  This device is intended exclusively for use in obstetric settings. It is a standalone system that combines uterine contraction and fetal heart monitoring capabilities. The monitor is not intended for third-party reprocessing or reuse, and it is supplied as a single-use or reusable system (depending on the components used) as part of its original packaging. It is regulated under 21 CFR 884.2740 and is classified as a Class II medical device.

• Is the Brattle Fetal Monitor, Part #100-11009 sterile?

  The provided device data does not specify whether the Brattle Fetal Monitor, Part #100-11009 is supplied in a sterile condition. Typically, fetal monitoring systems may include both sterile and non-sterile components, such as sensors or cables. For accurate information, refer to the manufacturer’s instructions for use or packaging details, which outline the sterility status of individual components and their intended handling procedures.

• What regulatory status does the Brattle Fetal Monitor, Part #100-11009 hold?

  The Brattle Fetal Monitor, Part #100-11009 received FDA 510(k) clearance under classification HGM (perinatal monitoring systems) in 1977. It was granted Substantially Equivalent (SESE) status by the Obstetrics/Gynecology advisory committee and remains unchanged in its regulatory status since clearance. This means it is considered equivalent to a legally marketed device that served as the predicate.

• Are there different models or sizes available for the Brattle Fetal Monitor, Part #100-11009?

  The provided data does not specify variations in models or sizes for the Brattle Fetal Monitor, Part #100-11009. However, the device is listed under multiple registration numbers, which may indicate different lot or batch identifiers rather than distinct models. For precise details on available configurations, consult the manufacturer’s documentation or contact Brattle Instrument Corp. directly.