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510(k) Data Aggregation
K Number
K981725Device Name
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
Manufacturer
Date Cleared
1999-02-02
(263 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
OPTOVENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Optovent™ RR 9700 is intended as an adjunct to patient assessment and is used to continuously monitor the respiratory rate of adult patients. The device is intended to be used by qualified health care professionals trained in the use of the equipment. The device is not intended for home use.
Device Description
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