510(k) K142832
K142832 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Unimed Disposable and Reusable SPO2 Sensors". The FDA issued a decision of Substantially Equivalent on February 6, 2015. 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
- February 6, 2015
- Date Received
- September 30, 2014
- 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