Lifetech Cardio Temporary Pacemaker
Summary
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. received 510(k) clearance for Lifetech Cardio Temporary Pacemaker, a DTE device. Cleared on 2024-01-07.
Details
Source
510(k) Clearance
External ID
K232721
Action Date
2024-01-07
Status
Special
Category
device
Product Code
DTE
Product Description
Lifetech Cardio Temporary Pacemaker. Product code: DTE.
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 Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232721" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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