510(k) K230145
K230145 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "ONE-CUF". The FDA issued a decision of Substantially Equivalent on March 14, 2023. The device falls under product code DXQ (Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2023
- Date Received
- January 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blood Pressure Cuff
- Device Class
- Class II
- Regulation Number
- 870.1120
- Review Panel
- CV
- Submission Type
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.