The following data is part of a premarket notification filed by Defibtech, Llc with the FDA for Defibtech Electrode Adapter, Model Dac-300 Series.
| Device ID | K033144 |
| 510k Number | K033144 |
| Device Name: | DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES |
| 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 | 2003-09-30 |
| Decision Date | 2003-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815098020485 | K033144 | 000 |
| 00815098020478 | K033144 | 000 |