The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Ddu-2300 Semiautomatic External Defibrillator And Accessories.
| Device ID | K081259 |
| 510k Number | K081259 |
| Device Name: | DDU-2300 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 | 2008-05-02 |
| Decision Date | 2009-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815098020492 | K081259 | 000 |
| 10815098020505 | K081259 | 000 |
| 10815098020451 | K081259 | 000 |
| 00815098020201 | K081259 | 000 |
| 00815098020225 | K081259 | 000 |
| 00815098020232 | K081259 | 000 |
| 00815098020393 | K081259 | 000 |
| 00815098020416 | K081259 | 000 |
| 00815098020447 | K081259 | 000 |
| 00815098020454 | K081259 | 000 |
| 10815098020499 | K081259 | 000 |