The following data is part of a premarket notification filed by Pennwalt Corp. with the FDA for Panorex Ii Dental X-ray Unit.
| Device ID | K800133 |
| 510k Number | K800133 |
| Device Name: | PANOREX II DENTAL X-RAY UNIT |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PENNWALT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-21 |
| Decision Date | 1980-03-03 |