The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Invacare 3g Tarsys.
Device ID | K033819 |
510k Number | K033819 |
Device Name: | INVACARE 3G TARSYS |
Classification | Wheelchair, Powered |
Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44035 -4190 |
Contact | Carroll Martin |
Correspondent | Carroll Martin INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44035 -4190 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-09 |
Decision Date | 2004-06-04 |
Summary: | summary |