The following data is part of a premarket notification filed by Medical Physics Instrumentation, Inc. with the FDA for Wellhofer Wp700 V. 3.2.
| Device ID | K945321 |
| 510k Number | K945321 |
| Device Name: | WELLHOFER WP700 V. 3.2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICAL PHYSICS INSTRUMENTATION, INC. 3080 STAGE POST DR., SUITE 109 Bartlett, TN 38133 |
| Contact | John R Bain |
| Correspondent | John R Bain MEDICAL PHYSICS INSTRUMENTATION, INC. 3080 STAGE POST DR., SUITE 109 Bartlett, TN 38133 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-07-12 |