OCR · Class II · 21 CFR 870.1875

FDA Product Code OCR: Lung Sound Monitor

The Lung Sound Monitor Is Intended For Use In Monitoring And Recording Lung Sounds.

Leading manufacturers include Deep Breeze , Ltd..

3
Total
3
Cleared
326d
Avg days
2007
Since

FDA 510(k) Cleared Lung Sound Monitor Devices (Product Code OCR)

3 devices
1–3 of 3
Cleared Mar 04, 2010
VRLXP, MODEL XP
K091732
Deep Breeze , Ltd.
Anesthesiology · 266d
Cleared Oct 15, 2008
VRIICU SYSTEM
K073582
Deep Breeze , Ltd.
Anesthesiology · 300d
Cleared Jul 18, 2007
VR LUNG ELECTROSONOGRAPH
K061495
Deep Breeze , Ltd.
Anesthesiology · 413d

About Product Code OCR - Regulatory Context