The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Minimon 7132 Patient Monitor.
Device ID | K844732 |
510k Number | K844732 |
Device Name: | KONTRON MINIMON 7132 PATIENT MONITOR |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Contact | George Cho |
Correspondent | George Cho KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-04 |
Decision Date | 1985-03-27 |