510(k) K100225
K100225 is an FDA 510(k) premarket notification submitted by Mediana Co., Ltd. for the device "PULSE OXIMETER MODEL P10". The FDA issued a decision of Substantially Equivalent on February 9, 2011. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Mediana Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2011
- Date Received
- January 26, 2010
- 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