The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for 0.015cc Pinpoint Ionization Chamber, 0.005 Cc Pinpoint Ionization Chamber.
| Device ID | K972212 |
| 510k Number | K972212 |
| Device Name: | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER |
| Classification | System, Radiation Therapy, Charged-particle, 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 | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-12 |
| Decision Date | 1997-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPTWTW310210 | K972212 | 000 |
| EPTWTM310160 | K972212 | 000 |
| EPTWTM310150 | K972212 | 000 |
| EPTWTM310140 | K972212 | 000 |
| EPTWTM310130 | K972212 | 000 |
| EPTWTM310110 | K972212 | 000 |
| EPTWTM310100 | K972212 | 000 |
| EPTWTL310210 | K972212 | 000 |
| EPTWTB310160 | K972212 | 000 |
| EPTWTB310150 | K972212 | 000 |
| EPTWTB310140 | K972212 | 000 |
| EPTWTB310130 | K972212 | 000 |
| EPTWTB310110 | K972212 | 000 |
| EPTWTM310210 | K972212 | 000 |
| EPTWTN310100 | K972212 | 000 |
| EPTWTW310160 | K972212 | 000 |
| EPTWTW310150 | K972212 | 000 |
| EPTWTW310140 | K972212 | 000 |
| EPTWTW310130 | K972212 | 000 |
| EPTWTW310110 | K972212 | 000 |
| EPTWTW310100 | K972212 | 000 |
| EPTWTN310210 | K972212 | 000 |
| EPTWTN310160 | K972212 | 000 |
| EPTWTN310150 | K972212 | 000 |
| EPTWTN310140 | K972212 | 000 |
| EPTWTN310130 | K972212 | 000 |
| EPTWTN310110 | K972212 | 000 |
| EPTWTB310100 | K972212 | 000 |