TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants— 510(k) K182891

Substantially Equivalent

Cs Medical, LLC

FDA 510(k) clearance K182891 for TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants, Substantially Equivalent on 2019-04-12. Applicant: Cs Medical, LLC. Device class: 2.

Clearance details

Applicant
Cs Medical, LLC
Product code
Code PSW
Device class
Class 2
Regulation
21 CFR 892.1570
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Creedmoor, NC, US
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