iHealth infrared Ear thermometer PT5
Summary
Andon Health Co, Ltd. received 510(k) clearance for iHealth infrared Ear thermometer PT5, a FLL device. Cleared on 2022-01-28.
Details
Source
510(k) Clearance
External ID
K212598
Action Date
2022-01-28
Status
Abbreviated
Category
device
Product Code
FLL
Product Description
iHealth infrared Ear thermometer PT5. Product code: FLL.
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. Andon Health Co, Ltd. has received 8 total clearances in our database.
Andon Health Co, Ltd. has 8 FDA actions in our database, including 8 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 Andon Health Co, Ltd. have FDA actions?
Andon Health Co, Ltd. has 8 FDA actions in our database, including 0 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212598" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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