The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Sdc4k Information Management System With Device And Voice Control Package.
| Device ID | K220108 |
| 510k Number | K220108 |
| Device Name: | SDC4K Information Management System With Device And Voice Control Package |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 |
| Contact | Divya Sekar |
| Correspondent | Divya Sekar Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-13 |
| Decision Date | 2022-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327562750 | K220108 | 000 |