Submission Details
| 510(k) Number | K230145 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 18, 2023 |
| Decision Date | March 14, 2023 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
ONE-CUF
Mar 2023
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K230145 is an FDA 510(k) clearance for the ONE-CUF, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 14, 2023, 55 days after receiving the submission on January 18, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.
Device Classification
| Product Code | DXQ — Blood Pressure Cuff |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1120 |
| Definition | A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure. |
Manufacturer
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI · US
Jennifer Strauther
31 submissions
31 cleared
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