DeviceClearance

Product code OCR— Cardiovascular

VR LUNG ELECTROSONOGRAPH

Classification name
Lung Sound Monitor
Device class
Class 2
Regulation
21 CFR 870.1875
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

FDA classification definition

“The lung sound monitor is intended for use in monitoring and recording lung sounds.”

— U.S. Food and Drug Administration, device classification record for product code OCR under 21 CFR 870.1875, via openFDA

Market context for product code OCR

FDA has cleared 3 devices under product code OCR between 2007 and 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OCR

Recent clearances under product code OCR

Data sourced from openFDA. This site is unofficial and independent of the FDA.