The following data is part of a premarket notification filed by Permobil Ab with the FDA for F5.
Device ID | K143014 |
510k Number | K143014 |
Device Name: | F5 |
Classification | Wheelchair, Powered |
Applicant | PERMOBIL AB PER UDDENS VAG 20 Timra, SE 86123 |
Contact | Jan Astrom |
Correspondent | Jan Astrom PERMOBIL AB PER UDDENS VAG 20 Timra, SE 86123 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-20 |
Decision Date | 2015-03-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17330818229844 | K143014 | 000 |