Phoresor Model PM2000
FDA 510(k) K001410 · Iomed, Inc.
510(k) numberK001410
Submission
- Device name
- Phoresor Model PM2000
- Applicant
- Iomed, Inc.
Salt Lake City, UT, US - Received
- May 4, 2000
- Decision date
- August 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTB – Device, Iontophoresis, Specific Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
Other 510(k)s with product code KTB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K895775 | CF Indicator Model 9800 Sweat Test SystemKTB · Traditional | Medtronic Vascular | 04/23/1990SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K063465 | Champion Iontophoretic Drug Delivery DeviceEGJ · Traditional | 02/28/2007SE |
| K060236 | MW-1000 Iontophoretic Drug Delivery ElectrodeEGJ · Traditional | 03/31/2006SE |
| K033192 | RH-950KTB · Traditional | 12/22/2003SE |
| K031115 | RH-900KTB · Traditional | 07/10/2003SE |
| K001522 | TRANSQ3KTB · Traditional | 10/18/2000SE |
| K982668 | Phoresor Ii,Model PM900EGJ · Traditional | 03/02/1999SE |
| K974855 | Phoresor II, Model PM900KTB · Traditional | 03/27/1998SN |
| K954126 | Transq Electrode Phoresor IIKTB · Traditional | 01/19/1996SN |
| K934335 | Phoresor II Auto, Model PM800 ModificationEGJ · Traditional | 07/26/1994SE |
| K932621 | RH-801/GS Model TRANSQ(R)1EGJ · Traditional | 07/26/1994SE |
Questions and answers
When was Phoresor Model PM2000 cleared by the FDA?
Phoresor Model PM2000 (K001410) received a 510(k) decision of Substantially Equivalent on August 1, 2000, 89 days after the submission was received.
What is the product code of K001410?
The FDA product code is KTB – Device, Iontophoresis, Specific Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.