Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
Summary
Zoll Circulation, Inc. received 510(k) clearance for Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System, a NZE device. Cleared on 2023-11-03.
Details
Source
510(k) Clearance
External ID
K231182
Action Date
2023-11-03
Status
Traditional
Category
device
Product Code
NZE
Product Description
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System. Product code: NZE.
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. Zoll Circulation, Inc. has received 5 total clearances in our database.
Zoll Circulation, Inc. has 35 FDA actions in our database, including 30 recalls and 5 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 Zoll Circulation, Inc. have FDA actions?
Zoll Circulation, Inc. has 35 FDA actions in our database, including 30 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231182" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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