NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
FDA 510(k) clearance K031551 · decided 2003-08-20
Clearance details
- K-number
- K031551
- Device name
- NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
- Applicant
- Vyteris, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-19
- Decision date
- 2003-08-20
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- KTB
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fair Lawn, NJ, US
- Third-party review
- No
- Expedited review
- No
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| 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.