The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Series 7050 Capnograph.
Device ID | K860556 |
510k Number | K860556 |
Device Name: | SERIES 7050 CAPNOGRAPH |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
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 | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-14 |
Decision Date | 1986-02-21 |