The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Easystand Evolv.
Device ID | K062402 |
510k Number | K062402 |
Device Name: | EASYSTAND EVOLV |
Classification | Chair, Positioning, Electric |
Applicant | INVACARE CORP. ONE INVACARE WAY Elyria, OH 44035 -4190 |
Contact | Ronald Clines |
Correspondent | Ronald Clines INVACARE CORP. ONE INVACARE WAY Elyria, OH 44035 -4190 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-17 |
Decision Date | 2006-09-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10858921006048 | K062402 | 000 |
10858921006031 | K062402 | 000 |
10858921006024 | K062402 | 000 |
10858921006017 | K062402 | 000 |
10858921006000 | K062402 | 000 |