The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Phoresor Ii,model Pm900.
Device ID | K982668 |
510k Number | K982668 |
Device Name: | PHORESOR II,MODEL PM900 |
Classification | Device, Iontophoresis, Other 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 | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-31 |
Decision Date | 1999-03-02 |
Summary: | summary |