The following data is part of a premarket notification filed by Wr Medical Electronics Co. with the FDA for Q-sweat Quantitative Sweat Measurement System.
Device ID | K992874 |
510k Number | K992874 |
Device Name: | Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM |
Classification | Device, Iontophoresis, Specific Uses |
Applicant | WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater, MN 55082 |
Contact | Patrick J Anderson |
Correspondent | Patrick J Anderson WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET Stillwater, MN 55082 |
Product Code | KTB |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-26 |
Decision Date | 1999-11-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00702173151885 | K992874 | 000 |