HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
Summary
Shanghai Handy Medical Equipment Co., Ltd. received 510(k) clearance for HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2), a MUH device. Cleared on 2022-06-22.
Details
Source
510(k) Clearance
External ID
K221008
Action Date
2022-06-22
Status
Traditional
Category
device
Product Code
MUH
Product Description
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2). 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 413 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 Shanghai Handy Medical Equipment Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Shanghai Handy Medical Equipment Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221008" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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