The following data is part of a premarket notification filed by Instrumentarium Corp. Imaging Division with the FDA for Orthopantomograph Op200, Op200d, And Orthoceph Oc200, Oc200d.
| Device ID | K043612 |
| 510k Number | K043612 |
| Device Name: | ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | INSTRUMENTARIUM CORP. IMAGING DIVISION 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Contact | Mark Mason |
| Correspondent | Mark Mason INSTRUMENTARIUM CORP. IMAGING DIVISION 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-30 |
| Decision Date | 2005-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872381 | K043612 | 000 |
| 06430035872374 | K043612 | 000 |