Schiller America, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Schiller America, Inc. makes
Schiller America, Inc. manufactures electrocardiogram (ECG) monitors, including portable and ambulatory devices like the CARDIOVIT AT-1, AT-5C, and AT-1C/AT-2C series, as well as multi-channel ECG recorders such as the CARDIOVIT CS-100 and CS-200. The company also produces pulse oximeters (e.g., MINISCOPE MS-3) and vital sign monitors like the MT-200 and MICROVIT MT-100. Spirovit devices (SP-100 and SP-200) are designed for respiratory function testing, measuring spirometry metrics.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Schiller America, Inc. is based in the United States.
Catalogue
Schiller Model Sp-100 Spirovit(Tm) Ref K896120
Regimes: 510(k) Registry: 510(k)Cardiovit At-1, P-80 Ref K946205
Regimes: 510(k) Registry: 510(k)Miniscope Ms-3 Ref K954066
Regimes: 510(k) Registry: 510(k)Mt-200 Ref K973751
Regimes: 510(k) Registry: 510(k)Cardiovit Cs-100 Ref K914970
Regimes: 510(k) Registry: 510(k)Cardiovit At-5C Ref K941462
Regimes: 510(k) Registry: 510(k)Cardiovit Cs-200 Ref K970879
Regimes: 510(k) Registry: 510(k)Schiller Model Sp-200 Spirovit(Tm) Ref K896121
Regimes: 510(k) Registry: 510(k)Cardiovit At-1C, At-2C Ref K953396
Regimes: 510(k) Registry: 510(k)Microvit Mt-100 Ref K973735
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Schiller America, Inc. have in the registry?
The registry currently lists 10 devices for Schiller America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Schiller America, Inc.'s devices?
Among its 10 most recently registered devices, Schiller America, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Schiller America, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Schiller America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Schiller America, Inc. in the registry?
The most recently registered devices listed for Schiller America, Inc. include SCHILLER MODEL SP-100 SPIROVIT(TM), CARDIOVIT AT-1, P-80, MINISCOPE MS-3 and MT-200.