The following data is part of a premarket notification filed by Padpro Llc. with the FDA for Padpro Model #2516.
Device ID | K020203 |
510k Number | K020203 |
Device Name: | PADPRO MODEL #2516 |
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 | 2002-01-22 |
Decision Date | 2002-05-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20653405065354 | K020203 | 000 |
20653405040092 | K020203 | 000 |
20653405042522 | K020203 | 000 |
20653405042539 | K020203 | 000 |
20653405042621 | K020203 | 000 |
20653405042638 | K020203 | 000 |
20653405042720 | K020203 | 000 |
10653405042730 | K020203 | 000 |
20653405064234 | K020203 | 000 |
20653405064258 | K020203 | 000 |
20653405040085 | K020203 | 000 |