The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for Unidos Universal Dosimeter Model 10002-with Tnc Connector, 10005-with Bnt Connector.
| Device ID | K951764 |
| 510k Number | K951764 |
| Device Name: | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR |
| 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 | 1995-04-17 |
| Decision Date | 1995-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPTWT100230 | K951764 | 000 |
| EPTWT100220 | K951764 | 000 |
| EPTWT100210 | K951764 | 000 |
| EPTWT100100 | K951764 | 000 |
| EPTWT100090 | K951764 | 000 |
| EPTWT100080 | K951764 | 000 |
| EPTWS1000090 | K951764 | 000 |