The following data is part of a premarket notification filed by Amertek Medical, Inc. with the FDA for Ameritek Brachytherapy Template.
Device ID | K011581 |
510k Number | K011581 |
Device Name: | AMERITEK BRACHYTHERAPY TEMPLATE |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island, FL 33404 |
Contact | Greg Wiita |
Correspondent | Greg Wiita AMERTEK MEDICAL, INC. 2655 N. OCEAN DR. #405 Singer Island, FL 33404 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-23 |
Decision Date | 2001-07-17 |
Summary: | summary |