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FDA Product Code

FDA Product Code PCV — Clearance Directory

Device Class
Class II
21 CFR Citation
876.1500

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K212201 PENTAX Medical Auto Leakage Tester SHA-P6 Pentax of America, Inc. 2021-10-01 Traditional PDF ↗
K123704 AUTOMATED ENDOSCOPE LEAK TESTER Olympus Medical Systems Corp. 2013-02-04 Traditional PDF ↗

Product code PCV · Class II · Gastroenterology, Urology. Data: openFDA.