The following data is part of a premarket notification filed by Radiation Products Design, Inc. with the FDA for Radio Therapy Treatment Chair.
Device ID | K150382 |
510k Number | K150382 |
Device Name: | Radio Therapy Treatment Chair |
Classification | Accelerator, Linear, Medical |
Applicant | RADIATION PRODUCTS DESIGN, INC. 5218 Barthel Industrial Drive Albertville, MN 55301 |
Contact | Howard Larson |
Correspondent | Howard Larson RADIATION PRODUCTS DESIGN, INC. 5218 Barthel Industrial Drive Albertville, MN 55301 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-18 |
Decision Date | 2015-09-16 |