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 |