The following data is part of a premarket notification filed by Midwest Analog & Digital, Inc. with the FDA for Bedside Patient Monitor W/modules.
| Device ID | K850619 |
| 510k Number | K850619 |
| Device Name: | BEDSIDE PATIENT MONITOR W/MODULES |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MIDWEST ANALOG & DIGITAL, INC. 16308 WEST GLENDALE DR. New Berlin, WI 53151 |
| Contact | James Utzerath |
| Correspondent | James Utzerath MIDWEST ANALOG & DIGITAL, INC. 16308 WEST GLENDALE DR. New Berlin, WI 53151 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-15 |
| Decision Date | 1985-06-06 |