TRANSQ3
FDA 510(k) clearance K001522 · decided 2000-10-18
Clearance details
- K-number
- K001522
- Device name
- TRANSQ3
- Applicant
- Iomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-16
- Decision date
- 2000-10-18
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- KTB
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Macroduct Advanced Model 3710 (K180627) | Elitechgroup, Inc. | 2018-07-27 |
| RH-950 (K033192) | Iomed, Inc. | 2003-12-22 |
| NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (K031551) | Vyteris, Inc. | 2003-08-20 |
| RH-900 (K031115) | Iomed, Inc. | 2003-07-10 |
| NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (K010031) | Wescor, Inc. | 2001-03-20 |
| PHORESOR MODEL PM2000 (K001410) | Iomed, Inc. | 2000-08-01 |
| Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (K992874) | Wr Medical Electronics Co. | 1999-11-18 |
| PHORESOR II, MODEL PM900 (K974855) | Iomed, Inc. | 1998-03-27 |
| TRANSQ ELECTRODE PHORESOR II (K954126) | Iomed, Inc. | 1996-01-19 |
| CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM (K895775) | Medtronic Vascular | 1990-04-23 |
| WESCOR MODEL 3700 WEBSTER SWEAT INDUCER (K853973) | Wescor, Inc. | 1985-10-16 |
| SYS MACRODUCT SWEAT COLLECTION SYS 3600 (K840472) | Wescor, Inc. | 1984-03-19 |
Recalls involving this device
No recalls on record reference this clearance.