510(k) K051305
- Device
- CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
- Applicant
- CS Medical LLC
- 510(k) number
- K051305
- Product code
- PSW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-18
- Date received
- 2005-05-19
- Regulation
- 892.1570
- Classification name
- High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BEN CHEMELLI
- Address
- 3248 Lake Woodard Dr. Raleigh NC US 27604 27604
FDA Registration Numbers#
- 1423929
- 2013736
- 3034286426
- 3005698329
Source Documents#
Other 510(k) Records For Product Code PSW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator | Cs Medical, LLC | 2023-11-21 |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | Cs Medical, LLC | 2023-06-07 |
| 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 |
| 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 |
| 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 |
| K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Pci Medical, Inc. | 2015-11-16 |
Legacy Summary#
summary
FDA Review#
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