KTB — Device, Iontophoresis, Specific Uses Class II
FDA Device Classification
Classification Details
- Product Code
- KTB
- Device Class
- Class II
- Regulation Number
- 890.5525
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K180627 | elitechgroup | Macroduct Advanced Model 3710 | July 27, 2018 |
| K033192 | iomed | RH-950 | December 22, 2003 |
| K031551 | vyteris | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) | August 20, 2003 |
| K031115 | iomed | RH-900 | July 10, 2003 |
| K010031 | wescor | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | March 20, 2001 |
| K001522 | iomed | TRANSQ3 | October 18, 2000 |
| K001410 | iomed | PHORESOR MODEL PM2000 | August 1, 2000 |
| K992874 | wr medical electronics | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM | November 18, 1999 |
| K974855 | iomed | PHORESOR II, MODEL PM900 | March 27, 1998 |
| K954126 | iomed | TRANSQ ELECTRODE PHORESOR II | January 19, 1996 |
| K895775 | medtronic vascular | CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM | April 23, 1990 |
| K853973 | wescor | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | October 16, 1985 |
| K840472 | wescor | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | March 19, 1984 |
| K832059 | medtronic vascular | IONOPHORELIC SWEAT STIM. CHLORIDE- | August 24, 1983 |
| K790205 | mcg | ELECTROAPPLICATOR MODEL C-1 | March 19, 1979 |
| K781700 | mcghan medical | IONOTPHORETIC APPLICATOR | November 3, 1978 |