The following data is part of a premarket notification filed by Aktina Medical Corp. with the FDA for Active Breathing Coordinator.
| Device ID | K131313 |
| 510k Number | K131313 |
| Device Name: | ACTIVE BREATHING COORDINATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Tony Spaccarotella |
| Correspondent | Tony Spaccarotella AKTINA MEDICAL CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2013-08-07 |
| Summary: | summary |