Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
Summary
Realcloud Imaging Inc. Dba Realcloud Imaging received 510(k) clearance for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20, a MUH device. Cleared on 2022-08-31.
Details
Source
510(k) Clearance
External ID
K221955
Action Date
2022-08-31
Status
Traditional
Category
device
Product Code
MUH
Product Description
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20. Product code: MUH.
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.
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 Realcloud Imaging Inc. Dba Realcloud Imaging have FDA actions?
This is the only FDA action we have on record for Realcloud Imaging Inc. Dba Realcloud Imaging in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221955" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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