Clearance Summary
MOBILE BATTERY SERVICE STATION (MBSS) received FDA 510(k) clearance under submission number K030898, sponsored by Ad Elektronik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-08-27.
- Submission: K030898
- Applicant / Sponsor: Ad Elektronik GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2003-08-27
Classification & Regulation
This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.