The following data is part of a premarket notification filed by Sano Transportgeraete Gmbh with the FDA for Liftkar Pt.
Device ID | K111858 |
510k Number | K111858 |
Device Name: | LIFTKAR PT |
Classification | Transport, Patient, Powered |
Applicant | SANO TRANSPORTGERAETE GMBH 428 BELLEAIRE LANE Downers Grove, IL 60515 |
Contact | Jeanine A Carroccio |
Correspondent | Jeanine A Carroccio SANO TRANSPORTGERAETE GMBH 428 BELLEAIRE LANE Downers Grove, IL 60515 |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-30 |
Decision Date | 2011-11-04 |
Summary: | summary |