510(k) K113727
K113727 is an FDA 510(k) premarket notification submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. for the device "SHENZHEN MED-LINK PULSE OXIMETER PROBE". The FDA issued a decision of Substantially Equivalent on March 21, 2013. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Med-Link Electronics Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2013
- Date Received
- December 19, 2011
- 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