The following data is part of a premarket notification filed by Weaver Medical with the FDA for Stat-20 Fluorometer.
| Device ID | K882677 |
| 510k Number | K882677 |
| Device Name: | STAT-20 FLUOROMETER |
| Classification | Fluorometer |
| Applicant | WEAVER MEDICAL 3165 WEST 4700 SOUTH Salt Lake City, UT 84118 |
| Contact | Weaver, D.d.s. |
| Correspondent | Weaver, D.d.s. WEAVER MEDICAL 3165 WEST 4700 SOUTH Salt Lake City, UT 84118 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-28 |
| Decision Date | 1988-07-12 |