K Number
K954350
Device Name
CARD GUARD MODEL CG-6500
Date Cleared
1996-09-10

(358 days)

Product Code
Regulation Number
870.2920
AI/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

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).

N/A