The following data is part of a premarket notification filed by Wellhofer Dosimetrie with the FDA for One Dimensional Water Phantom, Wp 1d.
| Device ID | K032594 |
| 510k Number | K032594 |
| Device Name: | ONE DIMENSIONAL WATER PHANTOM, WP 1D |
| Classification | Accelerator, Linear, Medical |
| Applicant | WELLHOFER DOSIMETRIE 3150 STAGE POST DR. SUITE 110 Bartlett, TN 38133 |
| Contact | Mark Marsico |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-22 |
| Decision Date | 2003-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EIBAM90063400 | K032594 | 000 |
| EIBAM90061100 | K032594 | 000 |
| EIBAM90061200 | K032594 | 000 |
| EIBAM90062500 | K032594 | 000 |
| EIBAM90062600 | K032594 | 000 |
| EIBAM90062700 | K032594 | 000 |
| EIBAM90062800 | K032594 | 000 |
| EIBAM90062900 | K032594 | 000 |
| EIBAM90063000 | K032594 | 000 |
| EIBAM90063300 | K032594 | 000 |
| EIBAM9006100V0010 | K032594 | 000 |