JAXClass II

Pneumotachometer

Anesthesiology · 21 CFR 868.2550

MDR events2All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances8All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Injury2

Most-reported manufacturers

Hans Rudolph, Inc.1 Medical Graphics Corp.1

Recalls

1 recall events for this product code

Philips Medical Systems (Cleveland) Inc
TerminatedSep 22, 2014
No packaging. The device is a computed tomography scanner.
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Z-2678-2014 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

8 clearances for this product code