The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Modification To Focus.
| Device ID | K022630 |
| 510k Number | K022630 |
| Device Name: | MODIFICATION TO FOCUS |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Contact | Mark Mason |
| Correspondent | Mark Mason INSTRUMENTARIUM CORP. 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 | 2002-08-07 |
| Decision Date | 2002-10-09 |
| Summary: | summary |