EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
Summary
DRTECH Corporation received 510(k) clearance for EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG, a MQB device. Cleared on 2022-11-18.
Details
Source
510(k) Clearance
External ID
K223124
Action Date
2022-11-18
Status
Special
Category
device
Product Code
MQB
Product Description
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG. Product code: MQB.
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. DRTECH Corporation has received 14 total clearances in our database.
DRTECH Corporation has 14 FDA actions in our database, including 14 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 DRTECH Corporation have FDA actions?
DRTECH Corporation has 14 FDA actions in our database, including 0 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223124" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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