K Number
K001543Device Name
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
Manufacturer
Date Cleared
2001-01-29
(257 days)
Product Code
Regulation Number
870.1130AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
More Information
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
N/A