The following data is part of a premarket notification filed by Cardiac Science, Inc. with the FDA for Powerheart Ecd.
Device ID | K052316 |
510k Number | K052316 |
Device Name: | POWERHEART ECD |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | CARDIAC SCIENCE, INC. 5474 FELTL ROAD Edina, MN 55343 |
Contact | Kenneth Olson |
Correspondent | Kenneth Olson CARDIAC SCIENCE, INC. 5474 FELTL ROAD Edina, MN 55343 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-25 |
Decision Date | 2006-01-03 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POWERHEART ECD 78619334 not registered Dead/Abandoned |
Cardiac Science Inc. 2005-04-28 |