The following data is part of a premarket notification filed by Stryker with the FDA for Connected Or Hub With Device And Voice Control.
Device ID | K192172 |
510k Number | K192172 |
Device Name: | Connected OR Hub With Device And Voice 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-12 |
Decision Date | 2019-09-09 |
Summary: | summary |