| Device Classification Name |
Unit, X-Ray, Extraoral With Timer
|
| 510(k) Number |
K923360 |
| Device Name |
PORT-XD |
| Applicant |
| Mobile Dental Equipment Corp. |
| 16604 SE 17th Pl. |
|
Bellevue,
WA
98008
|
|
| Applicant Contact |
PETER E MOORE |
| Correspondent |
| Mobile Dental Equipment Corp. |
| 16604 SE 17th Pl. |
|
Bellevue,
WA
98008
|
|
| Correspondent Contact |
PETER E MOORE |
| Regulation Number | 872.1800 |
| Classification Product Code |
|
| Date Received | 07/08/1992 |
| Decision Date | 03/30/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|