The following data is part of a premarket notification filed by Takara Belmont Corp. with the FDA for Belray Ii.
| Device ID | K093240 |
| 510k Number | K093240 |
| Device Name: | BELRAY II |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TAKARA BELMONT CORP. 101 BELMONT DRIVE Somerset, NJ 08873 -1204 |
| Contact | Kunihiko Soue |
| Correspondent | Kunihiko Soue TAKARA BELMONT CORP. 101 BELMONT DRIVE Somerset, NJ 08873 -1204 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2010-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04952195093939 | K093240 | 000 |
| 04952195093922 | K093240 | 000 |
| 04952195093915 | K093240 | 000 |
| 04952195093908 | K093240 | 000 |
| 04952195093809 | K093240 | 000 |