Advanced Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Advanced Medical Systems, Inc. makes
Advanced Medical Systems, Inc. manufactures ultrasound transducers (models US917 and US915), fetal monitoring devices including the IM77 intrapartum fetal monitor and fetal pulse detector (model DOP-1), fetal scalp spiral electrodes, physiological monitors (model PM-20A), and spirometers (PFM Professional 7000 and Pul-Tron 100K). The company also produces a treatment planning computer system (model RAD-8).
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Ultrasound Transducer, Model US917 Ref K952031
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Model IM77 Intrapartum Fetal Monitor Ref K940898
Regimes: 510(k) Registry: 510(k)Fetal Pulse Detector Model Dop-1 Ref K902190
Regimes: 510(k) Registry: 510(k)Pfm Professional 7000 Spirometer Ref K932278
Regimes: 510(k) Registry: 510(k)Fetal Scalp Spiral Electrode Ref K911657
Regimes: 510(k) Registry: 510(k)Model Pm-20A Physiological Monitor Ref K880756
Regimes: 510(k) Registry: 510(k)New Rad-8 Treatment Planning Computer System Ref K894568
Regimes: 510(k) Registry: 510(k)Pul-Tron 100K Professional Spirometer Ref K891672
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Medical Systems, Inc. have in the registry?
The registry currently lists 10 devices for Advanced Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Medical Systems, Inc.'s devices?
Among its 10 most recently registered devices, Advanced Medical Systems, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Advanced Medical Systems, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Advanced Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Medical Systems, Inc. in the registry?
The most recently registered devices listed for Advanced Medical Systems, Inc. include ULTRASOUND TRANSDUCER, MODEL US917, ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION, MODEL IM77 INTRAPARTUM FETAL MONITOR and FETAL PULSE DETECTOR MODEL DOP-1.