Search Results
Found 1 results
510(k) Data Aggregation
K Number
K060297Device Name
PEPER
Manufacturer
Date Cleared
2006-08-02
(177 days)
Product Code
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL MONITORS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The pePER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.
Device Description
The pePER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The pePER stores the ECG after the `record' button is depressed. The recording period is preset up to 40 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the pePER.
Ask a Question
Ask a specific question about this device
Page 1 of 1