PHORESOR II, MODEL PM900

Device, Iontophoresis, Specific 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 IDK974855
510k NumberK974855
Device Name:PHORESOR II, MODEL PM900
ClassificationDevice, Iontophoresis, Specific 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 CodeKTB  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-29
Decision Date1998-03-27
Summary:summary

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