The following data is part of a premarket notification filed by Coopersurgical Inc. with the FDA for G210 Invicell Plus With Signiphy Ph Monitoring.
| Device ID | K191020 |
| 510k Number | K191020 |
| Device Name: | G210 InviCell Plus With SignipHy PH Monitoring |
| Classification | Accessory, Assisted Reproduction, Exempt |
| Applicant | CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Kyle Hooper |
| Correspondent | Kyle Hooper CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | PUB |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-17 |
| Decision Date | 2020-01-14 |