IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (
Summary
Philips Medizin Systeme Boeblingen GmbH received 510(k) clearance for IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066), a MHX device. Cleared on 2023-08-22.
Details
Source
510(k) Clearance
External ID
K223574
Action Date
2023-08-22
Status
Traditional
Category
device
Product Code
MHX
Product Description
IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066). Product code: MHX.
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. Philips Medizin Systeme Boeblingen GmbH has received 6 total clearances in our database.
Philips Medizin Systeme Boeblingen GmbH has 6 FDA actions in our database, including 6 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 Philips Medizin Systeme Boeblingen GmbH have FDA actions?
Philips Medizin Systeme Boeblingen GmbH has 6 FDA actions in our database, including 0 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223574" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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