Delphi-MD System
Summary
Quantalx Neuroscience, Ltd. received 510(k) clearance for Delphi-MD System, a SFN device. Cleared on 2025-08-20.
Details
Source
510(k) Clearance
External ID
DEN250002
Action Date
2025-08-20
Status
Direct
Category
device
Product Code
SFN
Product Description
Delphi-MD System. Product code: SFN.
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. Quantalx Neuroscience, Ltd. has received 2 total clearances in our database.
Quantalx Neuroscience, Ltd. has 2 FDA actions in our database, including 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 Quantalx Neuroscience, Ltd. have FDA actions?
Quantalx Neuroscience, Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "DEN250002" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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