The following data is part of a premarket notification filed by Permobil Ab with the FDA for C350 Powered Wheelchair.
Device ID | K071650 |
510k Number | K071650 |
Device Name: | C350 POWERED WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | PERMOBIL AB BOX 120 Timra, SE S-861 23 |
Contact | Jan Astrom |
Correspondent | Jan Astrom PERMOBIL AB BOX 120 Timra, SE S-861 23 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-18 |
Decision Date | 2007-09-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17330818123456 | K071650 | 000 |