510(k) K120193

ANY VIEW PATIENT MONITORS by Guangdong Biolight Meditech Co., Ltd. — Product Code MWI

K120193 is an FDA 510(k) premarket notification submitted by Guangdong Biolight Meditech Co., Ltd. for the device "ANY VIEW PATIENT MONITORS". The FDA issued a decision of Substantially Equivalent on June 29, 2012. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Guangdong Biolight Meditech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
January 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type