The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ibed Wireless With Ibed Mobile.
Device ID | K202964 |
510k Number | K202964 |
Device Name: | IBed Wireless With IBed Mobile |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | Stryker Corporation 3800 E. Centre Avenue Portage, MI 49002 |
Contact | Cathy Friday |
Correspondent | Cathy Friday Stryker Corporation 3800 E. Centre Avenue Portage, MI 49002 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2021-06-18 |