Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
Summary
Murata Vios, Inc. received 510(k) clearance for Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software, a DRT device. Cleared on 2024-03-22.
Details
Source
510(k) Clearance
External ID
K232354
Action Date
2024-03-22
Status
Traditional
Category
device
Product Code
DRT
Product Description
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software. Product code: DRT.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Murata Vios, Inc. has received 2 total clearances in our database.
Murata Vios, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Murata Vios, Inc. have FDA actions?
Murata Vios, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232354" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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