510(k) K091732

Device: VRLXP, MODEL XP
Applicant: DEEP BREEZE LTD.
510(k) number: K091732
Product code: OCR
Decision: Substantially Equivalent (SESE)
Decision date: 2010-03-04
Date received: 2009-06-11
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: JEFF BAETZ
Address: 2001 Pennsylvania Ave. NW, Suite 950 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
K073582	VRIICU SYSTEM	Deep Breeze , Ltd.	2008-10-15
K061495	VR LUNG ELECTROSONOGRAPH	Deep Breeze , Ltd.	2007-07-18

Legacy Summary#

summary

FDA Review#

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