The following data is part of a premarket notification filed by Padpro Llc. with the FDA for Padpro Model 2001, 2001-s, 2001-c, 2001-eps.
| Device ID | K014209 |
| 510k Number | K014209 |
| Device Name: | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-21 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405076985 | K014209 | 000 |
| 20653405040009 | K014209 | 000 |
| 20653405040016 | K014209 | 000 |
| 20653405040030 | K014209 | 000 |
| 20653405042478 | K014209 | 000 |
| 20653405042485 | K014209 | 000 |
| 20653405042492 | K014209 | 000 |
| 20653405042577 | K014209 | 000 |
| 20653405042584 | K014209 | 000 |
| 10653405042594 | K014209 | 000 |
| 20653405042676 | K014209 | 000 |
| 20653405042683 | K014209 | 000 |
| 20653405042690 | K014209 | 000 |
| 20653405064272 | K014209 | 000 |
| 10653405064282 | K014209 | 000 |
| 20653405064296 | K014209 | 000 |
| 20653405004711 | K014209 | 000 |