Product code KTB— Physical Medicine
CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
- Classification name
- Device, Iontophoresis, Specific Uses
- Device class
- Class 2
- Regulation
- 21 CFR 890.5525
- Advisory panel
- Physical Medicine
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code KTB
FDA has cleared devices under product code KTB between 1978 and 2018, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2003
- 2001
- 2000
- 1999
- 1998
- 1996
- 1990
- 1985
- 1984
- 1983
- 1979
- 1978
Top applicants under product code KTB
Recent clearances under product code KTB
- K180627 — Macroduct Advanced Model 3710
- K033192 — RH-950
- K031551 — NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
- K031115 — RH-900
- K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
- K001522 — TRANSQ3
- K001410 — PHORESOR MODEL PM2000
- K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
- K974855 — PHORESOR II, MODEL PM900
- K954126 — TRANSQ ELECTRODE PHORESOR II
- K895775 — CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM
- K853973 — WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
- K840472 — SYS MACRODUCT SWEAT COLLECTION SYS 3600
- K832059 — IONOPHORELIC SWEAT STIM. CHLORIDE-
- K790205 — ELECTROAPPLICATOR MODEL C-1
- K781700 — IONOTPHORETIC APPLICATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.