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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular Diagnostic Devices
CFR Sub-Part
OCR
Lung Sound Monitor
2
Product Code
K
09
1732
VRLXP, MODEL XP
2
Cleared 510(K)
K
07
3582
VRIICU SYSTEM
2
Cleared 510(K)
K
06
1495
VR LUNG ELECTROSONOGRAPH
2
Cleared 510(K)
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Therapeutic Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
CFR Sub-Part
Monitoring Devices
CFR Sub-Part
Neurological Therapeutic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
AN
/
cardiovascular-diagnostic-devices
/
OCR
/
K061495
View Source
VR LUNG ELECTROSONOGRAPH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061495
510(k) Type
Traditional
Applicant
DEEP BREEZE LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/18/2007
Days to Decision
413 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular Diagnostic Devices
OCR
Lung Sound Monitor
K
09
1732
VRLXP, MODEL XP
K
07
3582
VRIICU SYSTEM
K
06
1495
VR LUNG ELECTROSONOGRAPH
Cardiovascular Monitoring Devices
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
Monitoring Devices
Neurological Therapeutic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
cardiovascular-diagnostic-devices
/
OCR
/
K061495
View Source
VR LUNG ELECTROSONOGRAPH
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061495
510(k) Type
Traditional
Applicant
DEEP BREEZE LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/18/2007
Days to Decision
413 days
Submission Type
Summary