510(k) K171087
K171087 is an FDA 510(k) premarket notification submitted by Crystal Medtech, LLC for the device "AXON IR Heat Lamp". The FDA issued a decision of Substantially Equivalent on July 7, 2017. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2017
- Date Received
- April 12, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type