Aerotel, Ltd.
Country not established FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Aerotel, Ltd. makes
Aerotel, Ltd. manufactures electrocardiograph (ECG) recorders and transmitters, including 12-lead ECG devices designed for remote monitoring and telephonic transmission. Their portfolio includes standalone transmitters, receiving consoles, and interfaces for transmitting ECG data over telephone lines, supporting both patient and clinical use.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) database. These products are intended for use in the United States, where regulatory compliance is required for market authorisation.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Heartline Transtelephonic Ecg Receiving Console Ref K930314
Regimes: 510(k) Registry: 510(k)Heart 400 Ecg Transmitter Ref K953762
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Heart 1001 Ref K931020
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Aerotel Ltd. Holon Central · IL FEI 3009079475
Frequently asked questions
How many devices does Aerotel, Ltd. have in the registry?
The registry currently lists 6 devices for Aerotel, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aerotel, Ltd.'s devices?
Among its 6 most recently registered devices, Aerotel, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Aerotel, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Aerotel, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Aerotel, Ltd. in the registry?
The most recently registered devices listed for Aerotel, Ltd. include HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER, HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER, HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE and HEART 400 ECG TRANSMITTER.
Which FDA establishments are linked to Aerotel, Ltd.?
1 FDA establishment is linked to Aerotel, Ltd. in the registry; they are listed on the company page.