510(k) K063641
K063641 is an FDA 510(k) premarket notification submitted by Shenzhen Creative Industry Co., Ltd. for the device "PC-60, NON-INVASIVEPULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on Jul 13, 2007. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Creative Industry Co., Ltd. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 2007
- Date Received
- Dec 7, 2006
- 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
- 510(k)