The following data is part of a premarket notification filed by Stryker Medical with the FDA for Stryker Eclipse Warming Stretcher.
Device ID | K912237 |
510k Number | K912237 |
Device Name: | STRYKER ECLIPSE WARMING STRETCHER |
Classification | Saw, Electrically Powered |
Applicant | STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
Contact | David Johnson |
Correspondent | David Johnson STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
Product Code | DWI |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-21 |
Decision Date | 1991-07-30 |