510(k) K163687
K163687 is an FDA 510(k) premarket notification submitted by Hermes Medical Solutions AB for the device "OLINDA EXM". The FDA issued a decision of Substantially Equivalent on July 19, 2017. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Hermes Medical Solutions AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2017
- Date Received
- December 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Scintillation (Gamma)
- Device Class
- Class I
- Regulation Number
- 892.1100
- Review Panel
- RA
- Submission Type