Corometrics Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Corometrics Medical Systems, Inc. makes
Corometrics Medical Systems, Inc. manufactures ultrasound transducers and monitors for obstetric and fetal monitoring, including linear/convex array sector scanners, endovaginal transducers, beltless tocotransducers, and watertight transducers. Their product line also includes uterine activity monitors designed for tracking fetal heart rate and contractions during pregnancy. These devices are used in clinical settings to assess fetal well-being and maternal health.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are intended for use in the United States, where they comply with applicable medical device standards. No additional registries or classifications are specified.
Catalogue
Ssd-620 Linear/Convex Array Sector Scanner Ref K880900
Regimes: 510(k) Registry: 510(k)MODEL600 Uterine Activity Monitor Ref K903623
Regimes: 510(k) Registry: 510(k)Aloka Ust-964P-5 Endovaginal Transducer Ref K905000
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Corometrics Medical Systems, Inc. have in the registry?
The registry currently lists 5 devices for Corometrics Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Corometrics Medical Systems, Inc.'s devices?
Among its 5 most recently registered devices, Corometrics Medical Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Corometrics Medical Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Corometrics Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Corometrics Medical Systems, Inc. in the registry?
The most recently registered devices listed for Corometrics Medical Systems, Inc. include SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER, MODEL600 UTERINE ACTIVITY MONITOR, ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER and CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER.