The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Phoresor Model Pm2000.
Device ID | K001410 |
510k Number | K001410 |
Device Name: | PHORESOR MODEL PM2000 |
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 (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-04 |
Decision Date | 2000-08-01 |