510(k) K061495

Device: VR LUNG ELECTROSONOGRAPH
Applicant: DEEP BREEZE LTD.
510(k) number: K061495
Product code: OCR
Decision: Substantially Equivalent (SESE)
Decision date: 2007-07-18
Date received: 2006-05-31
Regulation: 870.1875
Classification name: Lung Sound Monitor
Medical specialty: Cardiovascular
Review panel: Anesthesiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: PHILIP J PHILLIPS
Address: 2001 Pennsylvania Ave. NW Suite 575 Washington DC US 20006 20006

FDA Registration Numbers#

3009328501
3024822434
3010880718
3012360512
3010205626

Source Documents#

Other 510(k) Records For Product Code OCR #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K091732	VRLXP, MODEL XP	Deep Breeze , Ltd.	2010-03-04
K073582	VRIICU SYSTEM	Deep Breeze , Ltd.	2008-10-15

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases