The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for Ptw-mp3 & Ptw-mp3s Automatic Water Phantom.
| Device ID | K954165 |
| 510k Number | K954165 |
| Device Name: | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM |
| Classification | Accelerator, Linear, Medical |
| Applicant | PTW-NEW YORK CORP. 2437 GRAND AVE. Bellmore, NY 11710 |
| Contact | Stephen R Szeglin |
| Correspondent | Stephen R Szeglin PTW-NEW YORK CORP. 2437 GRAND AVE. Bellmore, NY 11710 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPTWT470030 | K954165 | 000 |
| EPTWT41020Q1Q0310 | K954165 | 000 |
| EPTWT41020Q1Q0010 | K954165 | 000 |
| EPTWT410190 | K954165 | 000 |
| EPTWT410170 | K954165 | 000 |
| EPTWT410150 | K954165 | 000 |
| EPTWT410120 | K954165 | 000 |
| EPTWT340090 | K954165 | 000 |
| EPTWT100390 | K954165 | 000 |
| EPTWT100380 | K954165 | 000 |
| EPTWT100370 | K954165 | 000 |
| EPTWT100160 | K954165 | 000 |
| EPTWT100150 | K954165 | 000 |
| EPTWT41022Q1Q0010 | K954165 | 000 |
| EPTWT41022Q1Q0210 | K954165 | 000 |
| EPTWT470020 | K954165 | 000 |
| EPTWT470010 | K954165 | 000 |
| EPTWT4316JU1820 | K954165 | 000 |
| EPTWT43163Y230A0 | K954165 | 000 |
| EPTWT43163Y115A0 | K954165 | 000 |
| EPTWT431620 | K954165 | 000 |
| EPTWT43160 | K954165 | 000 |
| EPTWT410500 | K954165 | 000 |
| EPTWT410390 | K954165 | 000 |
| EPTWT410320 | K954165 | 000 |
| EPTWT410290 | K954165 | 000 |
| EPTWT41026Q1Q0010 | K954165 | 000 |
| EPTWT100110 | K954165 | 000 |