The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Patient Monitor Model Cm130, 140.
Device ID | K810177 |
510k Number | K810177 |
Device Name: | PATIENT MONITOR MODEL CM130, 140 |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-22 |
Decision Date | 1981-02-25 |