510(k) K222213
K222213 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)". The FDA issued a decision of Substantially Equivalent on December 19, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Unimed Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2022
- Date Received
- July 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type