The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Skin Prep Analyzer.
Device ID | K874327 |
510k Number | K874327 |
Device Name: | SKIN PREP ANALYZER |
Classification | Tester, Electrode, Surface, Electrocardiographic |
Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Thomas Massopust |
Correspondent | Thomas Massopust MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | KRC |
CFR Regulation Number | 870.2370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-21 |
Decision Date | 1987-11-23 |