510(k) K163339
K163339 is an FDA 510(k) premarket notification submitted by Spectralmd, Inc. for the device "SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0". The FDA issued a decision of Substantially Equivalent on August 17, 2017. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Spectralmd, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2017
- Date Received
- November 28, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Blood-Flow, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2120
- Review Panel
- CV
- Submission Type