MONICA HEALTHCARE LTD

FDA Regulatory Profile

MONICA HEALTHCARE LTD appears in FDA public data with 1 recall, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2588-2017, Class II) was initiated on April 28, 2017. Its most recent 510(k) clearance was granted on August 27, 2014.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2588-2017Class IIMonica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an acApril 28, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K140862MONICA NOVII WIRELESS PATCH SYSTEMAugust 27, 2014
K112390MONICA AN24July 13, 2012
K112163MONICA IF24August 30, 2011
K101801MONICA AN24February 3, 2011