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510(k) K031115

RH-900 by Iomed, Inc. — Product Code KTB

K031115 is an FDA 510(k) premarket notification submitted by Iomed, Inc. for the device "RH-900". The FDA issued a decision of Substantially Equivalent on July 10, 2003. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525. Iomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2003
Date Received
April 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances by Iomed, Inc.

  • K063465 — CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE (February 28, 2007)
  • K060236 — MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE (March 31, 2006)
  • K033192 — RH-950 (December 22, 2003)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K982668 — PHORESOR II,MODEL PM900 (March 2, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K934335 — PHORESOR II AUTO, MODEL PM800 MODIFICATION (July 26, 1994)
  • K932620 — RH-806/GS MODEL TRANSQ(R)2 (July 26, 1994)

Other clearances for product code KTB

  • K180627 — Macroduct Advanced Model 3710 (July 27, 2018)
  • K033192 — RH-950 (December 22, 2003)
  • K031551 — NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (August 20, 2003)
  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K895775 — CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM (April 23, 1990)

FDA data resources