The following data is part of a premarket notification filed by Aktina Medical Corporation with the FDA for Active Breathing Coordinator.
| Device ID | K151097 |
| 510k Number | K151097 |
| Device Name: | Active Breathing Coordinator |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL CORPORATION 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Tony Spaccarotella |
| Correspondent | Tony Spaccarotella AKTINA MEDICAL CORPORATION 360 NORTH ROUTE 9W Congers, NY 10920 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-24 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071284 | K151097 | 000 |
| 05060191071277 | K151097 | 000 |