510(k) K093016
K093016 is an FDA 510(k) premarket notification submitted by Shenzhen Creative Industry Co., Ltd. for the device "VITAL SIGNS MONITOR". The FDA issued a decision of Substantially Equivalent on Mar 30, 2010. 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
- Mar 30, 2010
- Date Received
- Sep 29, 2009
- 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)