The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for Ptw Dosimetry Diode, T60008.
| Device ID | K010916 |
| 510k Number | K010916 |
| Device Name: | PTW DOSIMETRY DIODE, T60008 |
| Classification | Accelerator, Linear, Medical |
| Applicant | PTW-NEW YORK CORP. 201 PARK AVE. Hicksville, NY 11801 |
| Contact | Stephen R Szeglin |
| Correspondent | Stephen R Szeglin PTW-NEW YORK CORP. 201 PARK AVE. Hicksville, NY 11801 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2001-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPTWTW600200 | K010916 | 000 |
| EPTWTM600160 | K010916 | 000 |
| EPTWTM600170 | K010916 | 000 |
| EPTWTM600180 | K010916 | 000 |
| EPTWTM600190 | K010916 | 000 |
| EPTWTM600200 | K010916 | 000 |
| EPTWTN600080 | K010916 | 000 |
| EPTWTN600160 | K010916 | 000 |
| EPTWTN600170 | K010916 | 000 |
| EPTWTN600180 | K010916 | 000 |
| EPTWTN600190 | K010916 | 000 |
| EPTWTN600200 | K010916 | 000 |
| EPTWTW600160 | K010916 | 000 |
| EPTWTW600170 | K010916 | 000 |
| EPTWTW600180 | K010916 | 000 |
| EPTWTW600190 | K010916 | 000 |
| EPTWTM600080 | K010916 | 000 |