The following data is part of a premarket notification filed by Arcoma Ab with the FDA for 0180 Intuition, 0072 Precision.
| Device ID | K140683 |
| 510k Number | K140683 |
| Device Name: | 0180 INTUITION, 0072 PRECISION |
| Classification | System, X-ray, Stationary |
| Applicant | ARCOMA AB 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ACROMA AB 8870 RAVELLO COURT Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350008750098 | K140683 | 000 |