510(k) K101694
K101694 is an FDA 510(k) premarket notification submitted by Guangdong Biolight Meditech Co., Ltd. for the device "HANDHELD PULSE OXIMETER MODEL M800". The FDA issued a decision of Substantially Equivalent on September 8, 2010. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Guangdong Biolight Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2010
- Date Received
- June 16, 2010
- 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