The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Phoresor Ii, Model Pm900.
Device ID | K974855 |
510k Number | K974855 |
Device Name: | PHORESOR II, MODEL PM900 |
Classification | Device, Iontophoresis, Specific Uses |
Applicant | IOMED, INC. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | W. Tim Miller |
Correspondent | W. Tim Miller IOMED, INC. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
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 | 1997-12-29 |
Decision Date | 1998-03-27 |
Summary: | summary |