The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Nanoduct Neonatal Sweat Analysis System.
| Device ID | K010031 |
| 510k Number | K010031 |
| Device Name: | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM |
| Classification | Device, Iontophoresis, Specific Uses |
| 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 | KTB |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-03 |
| Decision Date | 2001-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540303418 | K010031 | 000 |
| 03661540301124 | K010031 | 000 |
| 03661540301964 | K010031 | 000 |
| 03661540301971 | K010031 | 000 |
| 03661540301988 | K010031 | 000 |
| 03661540301995 | K010031 | 000 |
| 03661540302008 | K010031 | 000 |
| 03661540302015 | K010031 | 000 |
| 03661540302329 | K010031 | 000 |
| 03661540303241 | K010031 | 000 |
| 03661540302022 | K010031 | 000 |