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Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—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)
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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Review Panel
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Review Panel
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Unknown
Review Panel
Last synced on 31 January 2025 at 11:05 pm
AN
/
subpart-b—cardiovascular-diagnostic-devices
/
OCR
/
K073582
View Source
VRIICU SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K073582
510(k) Type
Traditional
Applicant
DEEP BREEZE LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/2008
Days to Decision
300 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
OCR
Lung Sound Monitor
K
09
1732
VRLXP, MODEL XP
K
07
3582
VRIICU SYSTEM
K
06
1495
VR LUNG ELECTROSONOGRAPH
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
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
/
subpart-b—cardiovascular-diagnostic-devices
/
OCR
/
K073582
View Source
VRIICU SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K073582
510(k) Type
Traditional
Applicant
DEEP BREEZE LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/2008
Days to Decision
300 days
Submission Type
Summary