510(k) K031515
K031515 is an FDA 510(k) premarket notification submitted by Viasys Healthcare GmbH for the device "SPIROPRO SPO2". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Viasys Healthcare GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2003
- Date Received
- May 14, 2003
- 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