510(k) K180046
K180046 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Rad-97 and Accessories". The FDA issued a decision of Substantially Equivalent on Oct 23, 2018. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Masimo Corporation has 86 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2018
- Date Received
- Jan 8, 2018
- 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)