The following data is part of a premarket notification filed by Et Medical Devices Spa with the FDA for Walk400h.
| Device ID | K091054 |
| 510k Number | K091054 |
| Device Name: | WALK400H |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | ET MEDICAL DEVICES SPA 6, VIA DE ZINIS Cavareno(tn), IT 38011 |
| Contact | Luigo Bucchi |
| Correspondent | Luigo Bucchi ET MEDICAL DEVICES SPA 6, VIA DE ZINIS Cavareno(tn), IT 38011 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-13 |
| Decision Date | 2009-07-27 |