The following data is part of a premarket notification filed by Permobil A.b. with the FDA for Electro.
Device ID | K041219 |
510k Number | K041219 |
Device Name: | ELECTRO |
Classification | Wheelchair, Powered |
Applicant | PERMOBIL A.B. BOX 120 Timra, SE S-861 23 |
Contact | Jan' Astrom |
Correspondent | Jan' Astrom PERMOBIL A.B. 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 | 2004-05-10 |
Decision Date | 2004-08-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17330818889420 | K041219 | 000 |