The following data is part of a premarket notification filed by Padpro Llc. with the FDA for Padpro, Model 2603.
Device ID | K020288 |
510k Number | K020288 |
Device Name: | PADPRO, MODEL 2603 |
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 | 2002-01-28 |
Decision Date | 2002-02-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20653405064265 | K020288 | 000 |
20653405064241 | K020288 | 000 |
20653405042751 | K020288 | 000 |
20653405042652 | K020288 | 000 |
20653405042553 | K020288 | 000 |
20653405040122 | K020288 | 000 |
20653405040115 | K020288 | 000 |