The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Wescor Sweat.chek Sweat Conductivity Analyzer.
| Device ID | K863395 |
| 510k Number | K863395 |
| Device Name: | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
| Contact | Wayne K Barlow |
| Correspondent | Wayne K Barlow WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
| Product Code | CGZ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1988-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540303395 | K863395 | 000 |
| 03661540302336 | K863395 | 000 |