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510(k) Data Aggregation
K Number
K171235Device Name
OmniCap
Manufacturer
Date Cleared
2018-01-04
(252 days)
Product Code
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Respirion, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The use of the OmniCap™ capnometer is indicated to provide measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate of adult patients. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a qualified healthcare provider.
Environment of Use: Hospitals, Sub-acute care facilities and intra-hospital transport.
Device Description
The OmniCap system incorporates three parts:
- . OmniCap monitor
- . Sensor cartridge with a colorimetric litmus media
- AC power adapter .
The OmniCap monitor houses the electronics including the color sensor, a LED light source, a miniature vacuum pump, internal sample gas tubing, a rechargeable nickel metal hydride battery pack, and the user interface.
The OmniCap Sensor cartridge is a colorimetric litmus media sealed in a plastic cartridge with clear windows on each side.
The AC power adapter is IEC 60601-1 compliant. The AC power adapter converts supplied AC power to DC power to facilitate charging the battery.
The OmniCap unit can operate with or without the AC adapter connected and powered.
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