Clearance Summary
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY received FDA 510(k) clearance under submission number K141231, sponsored by Zeller Power Products (Battery Beast, LLC). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-11-25.
- Submission: K141231
- Applicant / Sponsor: Zeller Power Products (Battery Beast, LLC)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2014-11-25
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.