CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid

CS Medical LLC

The following data is part of a premarket notification filed by Cs Medical Llc with the FDA for Cs Medical Td-100 Transesophageal Probe Disinfector, Model Td-100, Cs Medical Td-5 High-level Disinfectant, Model Td-5.

Pre-market Notification Details

• Device ID: K051305
• 510k Number: K051305
• Device Name: CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
• Classification: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
• Applicant: CS Medical LLC 3248 LAKE WOODARD DR. Raleigh, NC 27604
• Contact: Ben Chemelli
• Correspondent: Ben Chemelli; CS Medical LLC 3248 LAKE WOODARD DR. Raleigh, NC 27604
• Product Code: PSW
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-05-19
• Decision Date: 2005-08-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B205TD5A1	K051305	000
B205TD100A0	K051305	000