Babylog VN800, Babylog VN600
Summary
Draegerwerk AG & CO Kgaa received 510(k) clearance for Babylog VN800, Babylog VN600, a CBK device. Cleared on 2023-05-16.
Details
Source
510(k) Clearance
External ID
K222207
Action Date
2023-05-16
Status
Traditional
Category
device
Product Code
CBK
Product Description
Babylog VN800, Babylog VN600. Product code: CBK.
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. Draegerwerk AG & CO Kgaa has received 6 total clearances in our database.
Draegerwerk AG & CO Kgaa has 7 FDA actions in our database, including 1 recall and 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 Draegerwerk AG & CO Kgaa have FDA actions?
Draegerwerk AG & CO Kgaa has 7 FDA actions in our database, including 1 recall and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K222207" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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