The following data is part of a premarket notification filed by Inpeco S.p.a. with the FDA for Flexlab 3.6, Accelerator A3600.
| Device ID | K121012 |
| 510k Number | K121012 |
| Device Name: | FLEXLAB 3.6, ACCELERATOR A3600 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | INPECO S.P.A. 11 VIA G. DI VITTORIO Segrate, Milan, IT 20090 |
| Contact | Roberto Tamborra |
| Correspondent | Roberto Tamborra INPECO S.P.A. 11 VIA G. DI VITTORIO Segrate, Milan, IT 20090 |
| Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-03 |
| Decision Date | 2012-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 7640172342503 | K121012 | 000 |
| 7640172341506 | K121012 | 000 |
| 07640172340004 | K121012 | 000 |
| 07640172342008 | K121012 | 000 |
| 07640172341001 | K121012 | 000 |