The following data is part of a premarket notification filed by Stryker with the FDA for Connectedor Hub With Device And Voice Control.
| Device ID | K181258 |
| 510k Number | K181258 |
| Device Name: | ConnectedOR Hub With Device And Voice Control |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Stryker 5900 Optical Court San Jose, CA 95138 |
| Contact | April Malmborg |
| Correspondent | April Malmborg Stryker 5900 Optical Court San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2018-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327419153 | K181258 | 000 |
| 07613327419146 | K181258 | 000 |