510(k) K172492
K172492 is an FDA 510(k) premarket notification submitted by Hitachi Healthcare Americas for the device "Optical Topography System ETG-4100". The FDA issued a decision of Substantially Equivalent on Aug 17, 2018. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Hitachi Healthcare Americas has 11 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 17, 2018
- Date Received
- Aug 17, 2017
- 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)