The following data is part of a premarket notification filed by Aat Alber Antriebstechnik Gmbh with the FDA for C-max+ (plus).
Device ID | K130864 |
510k Number | K130864 |
Device Name: | C-MAX+ (PLUS) |
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 | 2013-03-28 |
Decision Date | 2014-02-06 |
Summary: | summary |