The following data is part of a premarket notification filed by Zeller Power Products (battery Beast, Llc) with the FDA for Zp9141, Zp9146y, Zp9146w Non-rechargeable Battery.
Device ID | K141231 |
510k Number | K141231 |
Device Name: | ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | ZELLER POWER PRODUCTS (BATTERY BEAST, LLC) 3975 WEST POST ROAD Las Vegas, NV 89118 |
Contact | Douglas Austin |
Correspondent | Douglas Austin ZELLER POWER PRODUCTS (BATTERY BEAST, LLC) 3975 WEST POST ROAD Las Vegas, NV 89118 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-13 |
Decision Date | 2014-11-25 |
Summary: | summary |