The following data is part of a premarket notification filed by Stryker with the FDA for Connected Or Hub With Voice Control, Connected Or Hub With Device Control.
| Device ID | K201434 |
| 510k Number | K201434 |
| Device Name: | Connected OR Hub With Voice Control, Connected OR Hub With Device Control |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95131 |
| Contact | Meagan Jones |
| Correspondent | Meagan Jones Stryker 5900 Optical Court San Jose, CA 95131 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327512243 | K201434 | 000 |