The following data is part of a premarket notification filed by Lifeline Medical Systems, Inc. with the FDA for Cm 3000 The Monitor.
Device ID | K874898 |
510k Number | K874898 |
Device Name: | CM 3000 THE MONITOR |
Classification | Monitor, Breathing Frequency |
Applicant | LIFELINE MEDICAL SYSTEMS, INC. P.O. BOX 484 Tualatin, OR 97062 |
Contact | Freda Whitesel |
Correspondent | Freda Whitesel LIFELINE MEDICAL SYSTEMS, INC. P.O. BOX 484 Tualatin, OR 97062 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-01 |
Decision Date | 1988-03-21 |