Cleared Traditional

BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR

K000702 · Fresenius Medical Care North America · Gastroenterology & Urology
Jun 2000
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K000702 is an FDA 510(k) clearance for the BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR, a Protector, Transducer, Dialysis (Class II — Special Controls, product code FIB), submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on June 7, 2000, 98 days after receiving the submission on March 1, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K000702 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2000
Decision Date June 07, 2000
Days to Decision 98 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FIB — Protector, Transducer, Dialysis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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