510(k) K173187
K173187 is an FDA 510(k) premarket notification submitted by Philips India Limited for the device "MobileDiagnost M50". The FDA issued a decision of Substantially Equivalent on Nov 16, 2017. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Philips India Limited has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 2017
- Date Received
- Oct 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)