Calnor of EL Paseo, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Calnor of EL Paseo, Inc. makes
The company manufactures electrophysiological monitoring devices, including galvanic skin response (GSR) systems, electromyography (EMG) units such as the Clinical EMG Model 133, and electroencephalography (EEG) systems like the EEG 130. It also produces temperature monitoring devices (Model 132) and an ethylene oxide detector (GLD-1-07).
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Gsr, 126, Eeg 130-Temp. 132, Emg 133 Ref K841895
Regimes: 510(k) Registry: 510(k)Emg Model 133 Ref K842354
Regimes: 510(k) Registry: 510(k)Eeg 130 Ref K842288
Regimes: 510(k) Registry: 510(k)Temperature 132 Ref K842353
Regimes: 510(k) Registry: 510(k)Clinical Emg Model 133 Ref K771577
Regimes: 510(k) Registry: 510(k)Ethylene Oxide Detector Gld-1-07 Ref K834152
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Calnor of EL Paseo, Inc. have in the registry?
The registry currently lists 6 devices for Calnor of EL Paseo, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Calnor of EL Paseo, Inc.'s devices?
Among its 6 most recently registered devices, Calnor of EL Paseo, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Calnor of EL Paseo, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Calnor of EL Paseo, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Calnor of EL Paseo, Inc. in the registry?
The most recently registered devices listed for Calnor of EL Paseo, Inc. include GSR, 126, EEG 130-TEMP. 132, EMG 133, EMG MODEL 133, EEG 130 and TEMPERATURE 132.