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 |