HEARTONE EVENT RECORDER AND TRANSMITTER— 510(k) K023418
Substantially EquivalentAerotel Medical Systems (1998) , Ltd.
FDA 510(k) clearance K023418 for HEARTONE EVENT RECORDER AND TRANSMITTER, Substantially Equivalent on 2002-11-06. Applicant: Aerotel Medical Systems (1998) , Ltd..
Clearance details
- Applicant
- Aerotel Medical Systems (1998) , Ltd.
- Product code
- Code DXH
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hasbrouck Heights, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.