The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Aktina Medical Physics Corporation Active Breathing Coordinator (abc).
Device ID | K003330 |
510k Number | K003330 |
Device Name: | AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) |
Classification | Accelerator, Linear, Medical |
Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
Contact | Joan Zacharopoulos |
Correspondent | Joan Zacharopoulos AKTINA MEDICAL PHYSICS 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 | 2000-10-24 |
Decision Date | 2001-01-04 |