The following data is part of a premarket notification filed by Medical Devices/padpro, Inc. with the FDA for Defibrillator Cable Tester, Model Dt2200.
| Device ID | K061606 |
| 510k Number | K061606 |
| Device Name: | DEFIBRILLATOR CABLE TESTER, MODEL DT2200 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | MEDICAL DEVICES/PADPRO, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-09 |
| Decision Date | 2006-06-21 |
| Summary: | summary |