The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Ace Calibrator.
| Device ID | K141728 |
| 510k Number | K141728 |
| Device Name: | ACE CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Contact | Patricia Dupe |
| Correspondent | Patricia Dupe SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-26 |
| Decision Date | 2014-07-28 |
| Summary: | summary |