The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Ddu-2400/2450 Semiautomatic External Defibrillator And Accessories.
| Device ID | K121853 |
| 510k Number | K121853 |
| Device Name: | DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | DEFIBTECH, LLC 741 BOSTON POST ROAD Guilford, CT 06437 |
| Contact | Ed Horton |
| Correspondent | Ed Horton DEFIBTECH, LLC 741 BOSTON POST ROAD 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 | 2012-06-25 |
| Decision Date | 2012-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815098020515 | K121853 | 000 |
| 10815098020529 | K121853 | 000 |
| 00815098020249 | K121853 | 000 |
| 00815098020263 | K121853 | 000 |
| 00815098020270 | K121853 | 000 |
| 00815098020287 | K121853 | 000 |
| 00815098020300 | K121853 | 000 |
| 00815098020317 | K121853 | 000 |
| 00815098020409 | K121853 | 000 |
| 00815098020508 | K121853 | 000 |
| 10815098020512 | K121853 | 000 |