The following data is part of a premarket notification filed by Aat Alber Antriebstechnik Gmbh with the FDA for C-max, C-max U1, C-max U1 160kg, C-max U2, C-max U2 160kg, S-max, S-max Aviation, S-max Sella, S-max Sella 160kg.
| Device ID | K103122 |
| 510k Number | K103122 |
| Device Name: | C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG |
| Classification | Transport, Patient, Powered |
| Applicant | AAT ALBER ANTRIEBSTECHNIK GMBH 2611 SHARK CIRCLE Texas City, TX 77591 |
| Contact | Stefanie D Bankston |
| Correspondent | Stefanie D Bankston AAT ALBER ANTRIEBSTECHNIK GMBH 2611 SHARK CIRCLE Texas City, TX 77591 |
| Product Code | ILK |
| CFR Regulation Number | 890.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-21 |
| Decision Date | 2010-12-30 |
| Summary: | summary |