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510(k) Data Aggregation
K Number
K061962Device Name
SURGI-CUF REUSABLE, RS SERIES
Manufacturer
Date Cleared
2006-07-25
(13 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
ETHOX INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.
Device Description
The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems.
Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations:
Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)
Single Tube configuration with 6 types of connectors
Double Tube configuration with 2 types of connectors
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