Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K223907
Device Classification Name
More FDA Info for this Device
510(K) Number
K223907
Device Name
NuEra Tight RF Model APMD145.M70-US
Applicant
BIOS s.r.l.
Via Guido Rossa 10/12
Vimodrone 20055 IT
Other 510(k) Applications for this Company
Contact
Martina De Iturbe
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2022
Decision Date
05/02/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact