The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Strykerware System.
Device ID | K024159 |
510k Number | K024159 |
Device Name: | STRYKERWARE SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Evan Norton |
Correspondent | Evan Norton Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-17 |
Decision Date | 2003-03-10 |
Summary: | summary |