BLUE 400; BLUE 400 S
Summary
Carl Zeiss Meditec, AG received 510(k) clearance for BLUE 400; BLUE 400 S, a QFX device. Cleared on 2024-06-28.
Details
Source
510(k) Clearance
External ID
K240215
Action Date
2024-06-28
Status
Traditional
Category
device
Product Code
QFX
Product Description
BLUE 400; BLUE 400 S. Product code: QFX.
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. Carl Zeiss Meditec, AG has received 11 total clearances in our database.
Carl Zeiss Meditec, AG has 12 FDA actions in our database, including 1 recall and 11 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 Carl Zeiss Meditec, AG have FDA actions?
Carl Zeiss Meditec, AG has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240215" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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