Bedside Patient Monitor W/Modules
by Midwest Analog & Digital, Inc.
510(k) K850619
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850619 | Date6 Jun 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Cardiac Monitor (including cardiotachometer and rate alarm) designed for continuous bedside monitoring of cardiovascular parameters. It provides real-time assessment of heart rate and rhythm, supporting clinical decision-making in acute care settings.
The monitor is intended for single-use or reusable applications in hospital environments, adhering to Class II regulatory standards under FDA 510(k) clearance (K850619). Supplied as a modular system, it requires proper storage and handling per manufacturer guidelines, with no specific MRI safety restrictions noted. Authorized under regulation number 870.2300 for cardiovascular applications.
Other devices from Midwest Analog & Digital, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical parameters does this bedside monitor specifically track, and how does it support acute care decisions?
This device continuously monitors heart rate and rhythm in real-time, including cardiotachometer and rate alarm functions. By providing immediate cardiovascular assessments, it helps clinicians quickly identify abnormalities (e.g., arrhythmias) and make time-sensitive decisions in acute care settings like ICUs or emergency rooms.
Is this monitor designed for single-use or reusable applications, and what storage guidelines should I follow?
The device is intended for either single-use or reusable applications in hospital environments. Proper storage and handling must adhere to the manufacturer’s guidelines to maintain performance and safety, though specific sterility or reprocessing instructions are not detailed in the provided data.
Does this monitor have any restrictions regarding use in MRI environments?
The manufacturer does not specify any MRI safety restrictions for this device, meaning it is not explicitly labeled as MRI-safe or unsafe. However, clinicians should verify compatibility with their facility’s MRI protocols and consult the manufacturer’s documentation for guidance.
What regulatory pathway was used for FDA clearance, and what does that mean for its safety and performance?
This device received FDA 510(k) clearance (K850619) under the Traditional pathway, classified as Substantially Equivalent (SE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared monitor, ensuring it meets Class II regulatory standards for cardiovascular applications.
Are there multiple models or sizes available for this bedside monitor, and how can I identify the correct one for my needs?
The data lists multiple registration numbers (e.g., 3008717264, 3026751377, etc.), which may correspond to different models or configurations of the monitor. While exact specifications (e.g., screen size, feature variations) aren’t detailed, these identifiers can help verify compatibility with your facility’s requirements. Contact Midwest Analog & Digital, Inc. for model-specific details.