510(k) K914264
K914264 is an FDA 510(k) premarket notification submitted by Iomed, Inc. for the device "TRANSQ 2". The FDA issued a decision of Substantially Equivalent (kit, denovo) on December 20, 1991. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Iomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- December 20, 1991
- Date Received
- September 23, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Iontophoresis, Other Uses
- Device Class
- Class II
- Regulation Number
- 890.5525
- Review Panel
- PM
- Submission Type