The following data is part of a premarket notification filed by Stryker Medical with the FDA for Stryker Agility Intensive Care Bed.
Device ID | K946149 |
510k Number | K946149 |
Device Name: | STRYKER AGILITY INTENSIVE CARE BED |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | STRYKER MEDICAL 420 ALCOTT ST. Kalamazoo, MI 49001 -9799 |
Contact | Chad A Coberly |
Correspondent | Chad A Coberly STRYKER MEDICAL 420 ALCOTT ST. Kalamazoo, MI 49001 -9799 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-16 |
Decision Date | 1995-03-14 |