The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Orthoceph Oc100.
| Device ID | K930338 |
| 510k Number | K930338 |
| Device Name: | ORTHOCEPH OC100 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | INSTRUMENTARIUM CORP. P.O. BOX 20 (NAHKELENTIE 160) SF-04301 Tuusula, FI |
| Contact | Risto Mynttinen |
| Correspondent | Risto Mynttinen INSTRUMENTARIUM CORP. P.O. BOX 20 (NAHKELENTIE 160) SF-04301 Tuusula, FI |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-25 |
| Decision Date | 1993-04-27 |