The following data is part of a premarket notification filed by Tmrw Life Sciences, Inc. with the FDA for Cryorobot Select System.
| Device ID | K221086 |
| 510k Number | K221086 |
| Device Name: | CryoRobot Select System |
| Classification | Automated Cryopreservation Storage System |
| Applicant | TMRW Life Sciences, Inc. 250 Hudson Street Floor 6 New York, NY 10013 |
| Contact | Christina Miracle |
| Correspondent | Christina Miracle TMRW Life Sciences, Inc. 250 Hudson Street Floor 6 New York, NY 10013 |
| Product Code | QUJ |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-13 |
| Decision Date | 2022-11-04 |