The following data is part of a premarket notification filed by Stryker Communications with the FDA for Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000.
| Device ID | K100852 |
| 510k Number | K100852 |
| Device Name: | STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | STRYKER COMMUNICATIONS 1410 LAKESIDE PKWY., #100 Flower Mound, TX 75028 |
| Contact | Alma Relja |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | OCS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327303605 | K100852 | 000 |
| 07613327054255 | K100852 | 000 |
| 07613327054156 | K100852 | 000 |