The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Defibtech Aed With Attenuated Defibrillation/monitoring Pads, Models Ddu-100 With Ddp-200p.
| Device ID | K033896 |
| 510k Number | K033896 |
| Device Name: | DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | DEFIBTECH, LLC 753 BOSTON POST RD., SUITE 102 Guilford, CT 06437 |
| Contact | John L Rogers |
| Correspondent | John L Rogers DEFIBTECH, LLC 753 BOSTON POST RD., SUITE 102 Guilford, CT 06437 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-16 |
| Decision Date | 2004-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815098020430 | K033896 | 000 |
| 10815098020437 | K033896 | 000 |