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510(k) Data Aggregation
K Number
K102683Device Name
THE ADDITION
Manufacturer
Date Cleared
2011-01-06
(111 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
OB THE-ADDITION, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The-Addition provides padding for patient comfort and aids in the retention of coupling media in a defined position.
Device Description
The-Addition is a pad that is temporarily applied to the ultrasound transducer and the toco transducer to facilitate patient comfort and aid in the retention of ultrasonic coupling gel. The-Addition is provided non-sterile for single use and is disposable.
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