The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Belmax Cm Model X168.
| Device ID | K062529 |
| 510k Number | K062529 |
| Device Name: | BELMAX CM MODEL X168 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-29 |
| Decision Date | 2006-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560217094552 | K062529 | 000 |
| 04560217093616 | K062529 | 000 |