The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Mri Patient Positioning Devices.
Device ID | K080072 |
510k Number | K080072 |
Device Name: | MRI PATIENT POSITIONING DEVICES |
Classification | Accelerator, Linear, Medical |
Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Arthur Ward |
Correspondent | Arthur Ward CIVCO MEDICAL INSTRUMENTS CO., INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-11 |
Decision Date | 2008-06-04 |
Summary: | summary |