510(k) K111494
K111494 is an FDA 510(k) premarket notification submitted by Beijing Choice Electronic Technololgy Co., Ltd. for the device "HANDHELD PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on January 18, 2012. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Beijing Choice Electronic Technololgy Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2012
- Date Received
- May 31, 2011
- Clearance Type
- Special
- 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