The following data is part of a premarket notification filed by Minitube Of America, Inc with the FDA for Minitube Temperature Control Unit Sc-2000 + 2045.
| Device ID | K050197 |
| 510k Number | K050197 |
| Device Name: | MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 |
| Classification | Accessory, Assisted Reproduction |
| Applicant | MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 Madison, WI 53703 |
| Contact | Frederick T Rikkers |
| Correspondent | Frederick T Rikkers MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 Madison, WI 53703 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-27 |
| Decision Date | 2006-10-06 |