510(k) K181738
K181738 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service And Savings Inc (Dba Medline for the device "Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors". The FDA issued a decision of Substantially Equivalent on Mar 22, 2019. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 22, 2019
- Date Received
- Jul 2, 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)