The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Central Station Monitor Csm-100.
Device ID | K831818 |
510k Number | K831818 |
Device Name: | CENTRAL STATION MONITOR CSM-100 |
Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
Applicant | HONEYWELL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRT |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-06 |
Decision Date | 1983-10-31 |