The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Capnograph Monitor, Supermon Module 7281.
Device ID | K873396 |
510k Number | K873396 |
Device Name: | KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281 |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Contact | David Cromwick |
Correspondent | David Cromwick KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-24 |
Decision Date | 1988-06-21 |