International Biomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What International Biomedics, Inc. makes
International Biomedics, Inc. manufactures obstetrical imaging devices, including ultrasound transducers and handheld systems like the Fetascan 1000 and Fetascan 1500 for fetal imaging, as well as tocotonometers for measuring fetal heart rate via air-cushion technology. The company also provides modifications for transport incubators to support neonatal care.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. These devices are intended for use in the United States, where the manufacturer is based.
Catalogue
Air-Cushion Tocotonometer Ref K860933
Regimes: 510(k) Registry: 510(k)Fetascan 1500 Ref K860295
Regimes: 510(k) Registry: 510(k)Feta Scan 1000 Obstetrical Imager Ref K852439
Regimes: 510(k) Registry: 510(k)Modification To Transport Incubator 185 Ref K031096
Regimes: 510(k) Registry: 510(k)Fetascan Ultrasound Transducer Ibi# 101B00054-01 Ref K862072
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does International Biomedics, Inc. have in the registry?
The registry currently lists 5 devices for International Biomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Biomedics, Inc.'s devices?
Among its 5 most recently registered devices, International Biomedics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do International Biomedics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for International Biomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from International Biomedics, Inc. in the registry?
The most recently registered devices listed for International Biomedics, Inc. include AIR-CUSHION TOCOTONOMETER, FETASCAN 1500, FETA SCAN 1000 OBSTETRICAL IMAGER and MODIFICATION TO TRANSPORT INCUBATOR 185.