The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Sys Macroduct Sweat Collection Sys 3600.
| Device ID | K840472 |
| 510k Number | K840472 |
| Device Name: | SYS MACRODUCT SWEAT COLLECTION SYS 3600 |
| Classification | Device, Iontophoresis, Specific Uses |
| Applicant | WESCOR, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KTB |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-03 |
| Decision Date | 1984-03-19 |