The following data is part of a premarket notification filed by Padpro Llc. with the FDA for Padpro System Defibrillator Electrode Adapters.
Device ID | K003548 |
510k Number | K003548 |
Device Name: | PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS |
Classification | Automated External Defibrillators (non-wearable) |
Applicant | PADPRO LLC. P.O.BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm PADPRO LLC. P.O.BOX 7007 Deerfield, IL 60015 |
Product Code | MKJ |
CFR Regulation Number | 870.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-17 |
Decision Date | 2001-09-04 |