Carestation 750/750c
Summary
Datex-Ohmeda, Inc. received 510(k) clearance for Carestation 750/750c, a BSZ device. Cleared on 2023-03-28.
Details
Source
510(k) Clearance
External ID
K213867
Action Date
2023-03-28
Status
Traditional
Category
device
Product Code
BSZ
Product Description
Carestation 750/750c. Product code: BSZ.
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. Datex-Ohmeda, Inc. has received 5 total clearances in our database.
Datex-Ohmeda, Inc. has 29 FDA actions in our database, including 24 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 Datex-Ohmeda, Inc. have FDA actions?
Datex-Ohmeda, Inc. has 29 FDA actions in our database, including 24 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213867" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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