FDA 510(k) Application Details - K162763

Device Classification Name Lamp, Infrared, Therapeutic Heating

  More FDA Info for this Device
510(K) Number K162763
Device Name Lamp, Infrared, Therapeutic Heating
Applicant Vevazz, LLC
30520 Rancho California Rd, Suite 107-46
Temecula, CA 92591 US
Other 510(k) Applications for this Company
Contact Jamie Fettig
Other 510(k) Applications for this Contact
Regulation Number 890.5500

  More FDA Info for this Regulation Number
Classification Product Code ILY
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/30/2016
Decision Date 01/05/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact