Ziehm Vision FD
Summary
Ziehm Imaging GmbH received 510(k) clearance for Ziehm Vision FD, a OWB device. Cleared on 2025-03-13.
Details
Source
510(k) Clearance
External ID
K243735
Action Date
2025-03-13
Status
Traditional
Category
device
Product Code
OWB
Product Description
Ziehm Vision FD. Product code: OWB.
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. Ziehm Imaging GmbH has received 11 total clearances in our database.
Ziehm Imaging GmbH has 11 FDA actions in our database, including 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 Ziehm Imaging GmbH have FDA actions?
Ziehm Imaging GmbH has 11 FDA actions in our database, including 0 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243735" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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