FDA Product Code
FDA Product Code PSW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1570
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | Cs Medical, LLC | 2023-11-21 | Traditional | PDF ↗ |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | Cs Medical, LLC | 2023-06-07 | Traditional | PDF ↗ |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | Cs Medical, LLC | 2020-04-01 | Traditional | PDF ↗ |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | Cs Medical, LLC | 2019-04-12 | Traditional | PDF ↗ |
| K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant | Cs Medical, LLC | 2016-11-03 | Traditional | PDF ↗ |
| K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Pci Medical, Inc. | 2015-11-16 | Traditional | PDF ↗ |
| K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 | Cs Medical, LLC | 2005-08-18 | Traditional | PDF ↗ |
Product code PSW · Class II · Radiology. Data: openFDA.