The following data is part of a premarket notification filed by Stryker Medical with the FDA for Stryker Dynamic Mattress System (dms) Model #2500.
Device ID | K920526 |
510k Number | K920526 |
Device Name: | STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 |
Classification | Treadmill, Mechanical |
Applicant | STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
Contact | James A Ahle |
Correspondent | James A Ahle STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
Product Code | IOG |
CFR Regulation Number | 890.5370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-04 |
Decision Date | 1992-09-21 |