The following data is part of a premarket notification filed by Cs Medical L.l.c. with the FDA for Teeclean(r) Automated Tee Probe Cleaner Disinfector With Teezyme(r) Cleaner And Td-5(r) Or Td-8(r) High Level Disinfectants.
| Device ID | K182891 |
| 510k Number | K182891 |
| Device Name: | TEEClean(R) Automated TEE Probe Cleaner Disinfector With TEEZyme(R) Cleaner And TD-5(R) Or TD-8(R) High Level Disinfectants |
| Classification | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid |
| Applicant | CS Medical L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 |
| Contact | Kendall Ashe |
| Correspondent | Kendall Ashe CS Medical L.L.C. 2179 East Lyon Station Road Creedmoor, NC 27522 |
| Product Code | PSW |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2019-04-12 |