JFCClass I

System, Pressure Measurement, Intermittent

Physical Medicine · 21 CFR 890.1600

MDR events2All time

Recalls1All time

Registered firms41Currently listed

510(k) clearances11All time

Recent MDR events

2 adverse event reports on file

SMART CHECK¿ BY ROHO®Dec 5, 2019
InjuryRoho, Inc.1419507-2019-00008
T-ADAPTOR CLAMP, BLUE MONOTUBE TRIAX 20MMFeb 23, 2011
MalfunctionStryker Osteosynthesis Selzach8031020-2011-00048

Event type breakdown

Injury1

Malfunction1

Most-reported manufacturers

Roho, Inc.1 Stryker Osteosynthesis Selzach1

Recalls

1 recall events for this product code

Xsensor Technology Corporation
TerminatedJan 18, 2011
Product labeling of the X3 Display reads in part:
The plastic enclosures for the X3 Display and X3 PRO Pressure Mapping System has a UL94 HB flammability rating while the medical equipment specification UL 60601-1 requires V-2 rated plastic for electronic enclosures.
Z-0919-2011 · View FDA record ↗

Registered firms

41 firms currently registered for this product code

510(k) clearances

11 clearances for this product code