510(k) K082846
K082846 is an FDA 510(k) premarket notification submitted by APK Technology Co., Ltd. for the device "APK SPO2 PULSE OXIMETER SENSOR". The FDA issued a decision of Substantially Equivalent on April 3, 2009. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. APK Technology Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2009
- Date Received
- September 29, 2008
- 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