510(k) K895775
- Device
- Cf Indicator Model 9800 Sweat Test System
- Applicant
- MEDTRONIC VASCULAR
- 510(k) number
- K895775
- Product code
- KTB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-23
- Date received
- 1989-09-27
- Regulation
- 890.5525
- Classification name
- Device, Iontophoresis, Specific Uses
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WU, R.PH
- Address
- 7000 Central Ave., NE Minneapolis MN US 55432 55432
FDA Registration Numbers#
- 2118418
- 2011115
- 3017264244
- 1721293
- 1717966
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180627 | Macroduct Advanced Model 3710 | Elitechgroup, Inc. | 2018-07-27 |
| K033192 | RH-950 | Iomed, Inc. | 2003-12-22 |
| K031551 | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) | Vyteris, Inc. | 2003-08-20 |
| K031115 | RH-900 | Iomed, Inc. | 2003-07-10 |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | Wescor, Inc. | 2001-03-20 |
| K001522 | TRANSQ3 | Iomed, Inc. | 2000-10-18 |
| K001410 | PHORESOR MODEL PM2000 | Iomed, Inc. | 2000-08-01 |
| K992874 | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM | Wr Medical Electronics Co. | 1999-11-18 |
| K974855 | PHORESOR II, MODEL PM900 | Iomed, Inc. | 1998-03-27 |
| K954126 | TRANSQ ELECTRODE PHORESOR II | Iomed, Inc. | 1996-01-19 |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | Wescor, Inc. | 1985-10-16 |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | Wescor, Inc. | 1984-03-19 |
| K832059 | IONOPHORELIC SWEAT STIM. CHLORIDE- | Medtronic Vascular | 1983-08-24 |
| K790205 | ELECTROAPPLICATOR MODEL C-1 | Mcg, Inc. | 1979-03-19 |
| K781700 | IONOTPHORETIC APPLICATOR | Mcghan Medical Corp. | 1978-11-03 |