Protocol Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Protocol Systems, Inc. makes
Protocol Systems, Inc. manufactures cardiac monitoring devices, including portable ECG telemetry systems (e.g., PROPAQ series monitors with neonatal and impedance pneumography options), central station monitoring systems (e.g., Acuity and Model 100), and paper chart recorders (e.g., PAQ10). These devices are designed for real-time patient heart rhythm tracking, remote patient telemetry, and centralized cardiac monitoring in clinical and pre-hospital settings.
The company’s products are classified under FDA’s Class I and Class II categories, with regulatory authorisation supported by 510(k) clearances. Devices are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device regulations. Protocol Systems, Inc. is based in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Protocol Systems, Inc. have in the registry?
The registry currently lists 15 devices for Protocol Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Protocol Systems, Inc.'s devices?
Among its 15 most recently registered devices, Protocol Systems, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Protocol Systems, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Protocol Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Protocol Systems, Inc. in the registry?
The most recently registered devices listed for Protocol Systems, Inc. include PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS, PROPAQ ECG TELEMETRY OPTION, PAQ10 PAPER CHART RECORDER and MODEL ACUITY CENTRAL STATION.