The following data is part of a premarket notification filed by Poirier S.a. with the FDA for Airport Wheelchair.
Device ID | K840633 |
510k Number | K840633 |
Device Name: | AIRPORT WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | POIRIER S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-20 |
Decision Date | 1984-02-27 |