The following data is part of a premarket notification filed by Brymill Cryogenic Cystems with the FDA for Cry-actrackercam.
| Device ID | K110305 |
| 510k Number | K110305 |
| Device Name: | CRY-ACTRACKERCAM |
| Classification | Thermometer, Clinical Color Change |
| Applicant | BRYMILL CRYOGENIC CYSTEMS BUILDING 2, 105 WINDERMERE AVE Ellington, CT 06029 |
| Contact | Claudio Russo |
| Correspondent | Claudio Russo BRYMILL CRYOGENIC CYSTEMS BUILDING 2, 105 WINDERMERE AVE Ellington, CT 06029 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-02 |
| Decision Date | 2012-01-13 |