The following data is part of a premarket notification filed by Northwest Medical Physics Equipment, Inc. with the FDA for Preference Treatment System.
Device ID | K001833 |
510k Number | K001833 |
Device Name: | PREFERENCE TREATMENT SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. 21031 67TH AVE. WEST Lynnwood, WA 98036 |
Contact | Lee Myers |
Correspondent | Lee Myers NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. 21031 67TH AVE. WEST Lynnwood, WA 98036 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-16 |
Decision Date | 2000-09-28 |