The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Transq Electrode Phoresor Ii.
Device ID | K954126 |
510k Number | K954126 |
Device Name: | TRANSQ ELECTRODE PHORESOR II |
Classification | Device, Iontophoresis, Specific Uses |
Applicant | IOMED, INC. 1290 WEST 2320 SOUTH SUITE A Salt Lake City, UT 84119 |
Contact | Anne T Carter |
Correspondent | Anne T Carter IOMED, INC. 1290 WEST 2320 SOUTH SUITE A Salt Lake City, UT 84119 |
Product Code | KTB |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-01 |
Decision Date | 1996-01-19 |