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FDA Product Code

FDA Product Code KTB — Clearance Directory

Device Class
Class II
Assigned Panel
Physical Medicine
21 CFR Citation
890.5525

510(k) Clearances — 16 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K180627 Macroduct Advanced Model 3710 Elitechgroup, Inc. 2018-07-27 Traditional PDF ↗
K033192 RH-950 Iomed, Inc. 2003-12-22 Traditional PDF ↗
K031551 NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) Vyteris, Inc. 2003-08-20 Traditional PDF ↗
K031115 RH-900 Iomed, Inc. 2003-07-10 Traditional PDF ↗
K010031 NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM Wescor, Inc. 2001-03-20 Special PDF ↗
K001522 TRANSQ3 Iomed, Inc. 2000-10-18 Traditional PDF ↗
K001410 PHORESOR MODEL PM2000 Iomed, Inc. 2000-08-01 Traditional PDF ↗
K992874 Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM Wr Medical Electronics Co. 1999-11-18 Traditional PDF ↗
K974855 PHORESOR II, MODEL PM900 Iomed, Inc. 1998-03-27 Traditional PDF ↗
K954126 TRANSQ ELECTRODE PHORESOR II Iomed, Inc. 1996-01-19 Traditional PDF ↗
K895775 CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM Medtronic Vascular 1990-04-23 Traditional PDF ↗
K853973 WESCOR MODEL 3700 WEBSTER SWEAT INDUCER Wescor, Inc. 1985-10-16 Traditional PDF ↗
K840472 SYS MACRODUCT SWEAT COLLECTION SYS 3600 Wescor, Inc. 1984-03-19 Traditional PDF ↗
K832059 IONOPHORELIC SWEAT STIM. CHLORIDE- Medtronic Vascular 1983-08-24 Traditional PDF ↗
K790205 ELECTROAPPLICATOR MODEL C-1 Mcg, Inc. 1979-03-19 Traditional PDF ↗
K781700 IONOTPHORETIC APPLICATOR Mcghan Medical Corp. 1978-11-03 Traditional PDF ↗

Product code KTB · Class II · Physical Medicine. Data: openFDA.