PHORESOR II,MODEL PM900

Device, Iontophoresis, Other Uses

IOMED, INC.

The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Phoresor Ii,model Pm900.

Pre-market Notification Details

Device IDK982668
510k NumberK982668
Device Name:PHORESOR II,MODEL PM900
ClassificationDevice, Iontophoresis, Other Uses
Applicant IOMED, INC. 3385 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactW.tim Miller
CorrespondentW.tim Miller
IOMED, INC. 3385 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-31
Decision Date1999-03-02
Summary:summary

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