Brattle Instrument Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
What Brattle Instrument Corp. makes
Brattle Instrument Corp. manufactures physiological monitoring devices, including synchronizers for medical signal coordination, transcutaneous blood oxygen monitors, and fetal monitoring systems. Their portfolio includes abdominal ECG processors for fetal monitoring and standalone fetal monitors designed for obstetric use.
The company’s devices are classified under FDA’s Class I and Class II regulations, with relevant products listed via the 510(k) pathway. Their products are registered under U.S. FDA oversight and comply with applicable U.S. medical device regulations.
Catalogue
Phipiological Synchronizer PART#205 Ref K781681
510(k) 510(k)Synchronizer #208 Ref K810588
510(k) 510(k)Transcutaneous Blood Oxygen Monitor #300 Ref K802978
510(k) 510(k)Fetal Monitor, Part #100-11009 Ref K770297
510(k) 510(k)Monitor, Fetal, No. L04-1100 Ref K770692
510(k) 510(k)Abdominal Ecg Processor For Fetal Moni. Ref K770295
510(k) 510(k)Fetal Monitor, Part #101-11009 Ref K770296
510(k) 510(k)
Frequently asked questions
How many devices does Brattle Instrument Corp. have in the registry?
The registry currently lists 7 devices for Brattle Instrument Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brattle Instrument Corp.'s devices?
Among its 7 most recently registered devices, Brattle Instrument Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Brattle Instrument Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Brattle Instrument Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Brattle Instrument Corp. in the registry?
The most recently registered devices listed for Brattle Instrument Corp. include PHIPIOLOGICAL SYNCHRONIZER PART#205, SYNCHRONIZER #208, TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 and FETAL MONITOR, PART #100-11009.