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 |