The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (electrodes) Ddp-100; Battery Pack 1200mah; Ba.
| Device ID | K013896 |
| 510k Number | K013896 |
| Device Name: | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | DEFIBTECH, LLC 1200 BOSTON POST RD. SUITE 207 Guilford, CT 06437 |
| Contact | Gintaras Vaisnys |
| Correspondent | Gintaras Vaisnys DEFIBTECH, LLC 1200 BOSTON POST RD. SUITE 207 Guilford, CT 06437 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815098020423 | K013896 | 000 |
| 00815098020379 | K013896 | 000 |
| 00815098020362 | K013896 | 000 |
| 00815098020034 | K013896 | 000 |
| 00815098020027 | K013896 | 000 |
| 00815098020010 | K013896 | 000 |
| 00815098020003 | K013896 | 000 |