The following data is part of a premarket notification filed by Thyssenkrupp Accessibility B.v. with the FDA for Levant, Homeglide.
Device ID | K121560 |
510k Number | K121560 |
Device Name: | LEVANT, HOMEGLIDE |
Classification | Transport, Patient, Powered |
Applicant | THYSSENKRUPP ACCESSIBILITY B.V. VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL Zuid-holland, NL 2921 Ln |
Contact | Arnold Heiden |
Correspondent | Arnold Heiden THYSSENKRUPP ACCESSIBILITY B.V. VAN UTRECHTWEG 99 KRIMPEN AAN DEN IJSSEL Zuid-holland, NL 2921 Ln |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-29 |
Decision Date | 2012-11-01 |
Summary: | summary |