The following data is part of a premarket notification filed by Takara Belmont Corporation with the FDA for Phot-x Iis Model 505.
| Device ID | K141293 |
| 510k Number | K141293 |
| Device Name: | PHOT-X IIS MODEL 505 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TAKARA BELMONT CORPORATION 1120 BLOOMFILED AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff TAKARA BELMONT CORPORATION 1120 BLOOMFILED AVE. West Caldwell, NJ 07006 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-19 |
| Decision Date | 2014-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04952195280384 | K141293 | 000 |
| 04952195196258 | K141293 | 000 |
| 04952195248247 | K141293 | 000 |
| 04952195249213 | K141293 | 000 |
| 04952195250424 | K141293 | 000 |
| 04952195277056 | K141293 | 000 |
| 04952195277063 | K141293 | 000 |
| 04952195278534 | K141293 | 000 |
| 04952195278541 | K141293 | 000 |
| 04952195142248 | K141293 | 000 |