Ionotphoretic Applicator
FDA 510(k) K781700 · Mcghan Medical Corp.
510(k) numberK781700
Submission
- Device name
- Ionotphoretic Applicator
- Applicant
- Mcghan Medical Corp.
Walker, MI, US - Received
- October 10, 1978
- Decision date
- November 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTB – Device, Iontophoresis, Specific Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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|---|---|---|---|
| K180627 | Macroduct Advanced Model 3710KTB · Traditional | Elitechgroup, Inc. | 07/27/2018SE |
| K033192 | RH-950KTB · Traditional | Iomed, Inc. | 12/22/2003SE |
| K031551 | Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)KTB · Traditional | Vyteris, Inc. | 08/20/2003SE |
| K031115 | RH-900KTB · Traditional | Iomed, Inc. | 07/10/2003SE |
| K010031 | Nanoduct Neonatal Sweat Analysis SystemKTB · Special | Wescor, Inc. | 03/20/2001SE |
| K001522 | TRANSQ3KTB · Traditional | Iomed, Inc. | 10/18/2000SE |
| K001410 | Phoresor Model PM2000KTB · Traditional | Iomed, Inc. | 08/01/2000SE |
| K992874 | Q-Sweat Quantitative Sweat Measurement SystemKTB · Traditional | Wr Medical Electronics Co. | 11/18/1999SE |
| K974855 | Phoresor II, Model PM900KTB · Traditional | Iomed, Inc. | 03/27/1998SN |
| K954126 | Transq Electrode Phoresor IIKTB · Traditional | Iomed, Inc. | 01/19/1996SN |
More from Iomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873476 | Mini-Motor Hand Engine & Access. Dermabrasion BursGEY · Traditional | 09/11/1987SE |
| K873475 | Micro-Torque Hand Engine & Access. Dermabra. BursGEY · Traditional | 09/11/1987SE |
| K870754 | Mcghan Tissue Expander Fill SystemLCJ · Traditional | 03/31/1987SE |
| K864185 | Mcghan Longterm Mammary Expander, RTV DesignLCJ · Traditional | 12/24/1986SE |
| K864184 | Mcghan Longterm Mammary Expander/Gel-Saline DesignLCJ · Traditional | 12/24/1986SE |
| K862203 | Mcghan Magna-Site(Tm) Tissue ExpanderLCJ · Traditional | 07/23/1986SE |
| K854794 | Mcghan Integral Valve Tissue ExpanderLCJ · Traditional | 12/24/1985SE |
| K853014 | Mcghan Tissue Expander Fill KitLCJ · Traditional | 09/18/1985SE |
| K843704 | Mcghan Tissue ExpanderLCJ · Traditional | 10/31/1984SE |
| K781087 | Medical Grade Silicone Elastomer TubingFPK · Traditional | 11/22/1978SE |
Questions and answers
When was Ionotphoretic Applicator cleared by the FDA?
Ionotphoretic Applicator (K781700) received a 510(k) decision of Substantially Equivalent on November 3, 1978, 24 days after the submission was received.
What is the product code of K781700?
The FDA product code is KTB – Device, Iontophoresis, Specific Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.