SP-1000, SP-2000
Summary
Daesung Maref Co., Ltd. received 510(k) clearance for SP-1000, SP-2000, a IRP device. Cleared on 2021-09-01.
Details
Source
510(k) Clearance
External ID
K202395
Action Date
2021-09-01
Status
Traditional
Category
device
Product Code
IRP
Product Description
SP-1000, SP-2000. Product code: IRP.
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 389 device clearances issued this month. Daesung Maref Co., Ltd. has received 2 total clearances in our database.
Daesung Maref Co., 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 Daesung Maref Co., Ltd. have FDA actions?
Daesung Maref Co., 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 "K202395" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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