The following data is part of a premarket notification filed by Inarex Corporation with the FDA for Inarex, Model 2d-lx.
Device ID | K080554 |
510k Number | K080554 |
Device Name: | INAREX, MODEL 2D-LX |
Classification | Table, Physical Therapy, Multi Function |
Applicant | INAREX CORPORATION FLEMINGTON CT. # 155 La Mirada, CA 90638 |
Contact | Brandon Choi |
Correspondent | Brandon Choi INAREX CORPORATION FLEMINGTON CT. # 155 La Mirada, CA 90638 |
Product Code | JFB |
CFR Regulation Number | 890.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-28 |
Decision Date | 2008-08-27 |
Summary: | summary |