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510(k) K790205

ELECTROAPPLICATOR MODEL C-1 by Mcg, Inc. — Product Code KTB

K790205 is an FDA 510(k) premarket notification submitted by Mcg, Inc. for the device "ELECTROAPPLICATOR MODEL C-1". The FDA issued a decision of Substantially Equivalent on March 19, 1979. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1979
Date Received
January 31, 1979
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 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)
  • K031115 — RH-900 (July 10, 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)

FDA data resources