The following data is part of a premarket notification filed by Garaventa (canada) Ltd [dba Garaventa Lift] with the FDA for Garaventa X3 Inclined Platform Lift.
| Device ID | K122206 |
| 510k Number | K122206 |
| Device Name: | GARAVENTA X3 INCLINED PLATFORM LIFT |
| Classification | Permanently Mounted Wheelchair Platform Lift |
| Applicant | GARAVENTA (CANADA) LTD [DBA GARAVENTA LIFT] 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour GARAVENTA (CANADA) LTD [DBA GARAVENTA LIFT] 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | PCE |
| CFR Regulation Number | 890.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B24005 | K122206 | 000 |