The following data is part of a premarket notification filed by Takara Belmont Corporation with the FDA for Bel-cypher N.
| Device ID | K110160 |
| 510k Number | K110160 |
| Device Name: | BEL-CYPHER N |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TAKARA BELMONT CORPORATION 101 BELMONT DR Somerset, NJ 08873 |
| Contact | Kunihiko Sobue |
| Correspondent | Kunihiko Sobue TAKARA BELMONT CORPORATION 101 BELMONT DR Somerset, NJ 08873 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-19 |
| Decision Date | 2011-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560217093692 | K110160 | 000 |