The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Vitalmon 5010 Patient Monitor.
Device ID | K852249 |
510k Number | K852249 |
Device Name: | KONTRON VITALMON 5010 PATIENT MONITOR |
Classification | Monitor, Breathing Frequency |
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 | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-23 |
Decision Date | 1986-10-16 |