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510(k) Data Aggregation
K Number
K132405Device Name
PPA/BT-RB STETHOSCOPE
Manufacturer
RNK PRODUCTS, INC.
Date Cleared
2013-10-11
(70 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
RNK PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RNK PPA/BT-RB Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on a patient.
Device Description
The RNK PPA/BT-RB Stethoscope is comprised of a PCP Chest Piece assembly, an Amplifier Module containing an amplifier which amplifies the signal from the PCP Chest Piece and a Bluetooth wireless transmitter, and a standard audio Headset, plus an optional Bluetooth Headset.
The PCP Chest Piece assembly includes an attached cable terminated in a standard 3.5 mm audio stereo plug, which plugs into the Chest Piece port of the Amplifier Module. A standard, off-theshelf Headset with a 3.5 mm stereo audio plug can plug into the Headset port of the Amplifier Module to enable a listener to hear the amplified sounds from the PCP Chest Piece. Optionally, an off-the-shelf Bluetooth Headset can be used to listen to the signal from the PCP Chest Piece over a Bluetooth connection to the Bluetooth transmitter in the Amplifier Module.
The RNK Amplifier is powered by x2 AAA NiMH batteries, which can be recharged from a wall mount 5vdc power supply with a micro-USB connector. The Ampifier Module is not functional as a stethoscope while the batteries are being charged.
The RNK PPA/BT-RB Stethoscope provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. The overall auscultation frequency response of the RNK PPA/BT-RB Stethoscope is 20 Hz - 1,500 Hz.
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K Number
K132560Device Name
PCP-USB STETHOSCOPE
Manufacturer
RNK PRODUCTS, INC.
Date Cleared
2013-10-11
(57 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
RNK PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RNK PCP-USB Stethoscope is intended to transmit auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations.
Device Description
The PCP-USB Stethoscope consists of a hardware element, the PCP-Chest Piece, and software elements consisting of some audio signal processing in the Streaming Stethoscope Over IP (sSOIP) Anywhere software on the end station PCs, communications software on the end station PCs (sSOIP Anywhere), and communications networking software on the Telemedicine Communications Server (TMCS), Relay Server and Stethoscope User Data (SUD) Server. It provides remote auscultation between a patient at one location and a clinician at another location.
The PCP-USB Chest Piece contains an embedded piezo sensor, audio amplifier Analog to Digital Converter (ADC) and Encoder to create a digitized stream, plus a USB interface to send that data to the PC. The PCP-USB Chest Piece derives its operating voltage from the 5v lead of the USB interface to the PC.
Under direction of the sSOIP Anywhere program in the PC, the digitized signal is formatted in the PC into IP packets for transmit end station (i.e. patient end) and the receive end station (i.e. clinician end) log into the TMCS, which indicates their availability for a connection.
In the sSOIP Anywhere program, the clinician at the receive end, selects a patient from a list of available patients and initiates a connection request to the TMCS, which passes on the request to the patient station. When the patient accepts the incoming connection request in the sSOIP Anywhere program, the TMCS facilitates a direct (peer-to-peer) connection between the two parties. If a direct connection is not possible, the TMCS facilitates a relay connection between the two parties through a Relay Server. No patient stethoscope data passes through the TMCS.
At the receive end PC, the sSOIP Anywhere program directs the acceptance of the IP packets, conversion of the digitized signal back to analog and presentation of the analog signal to the Headset port of the PC.
The TMCS receives information on users that are permitted to use the TMCS services from a SUD Server. That information would be entered into the SUD Server by the health care provider responsible for those users.
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K Number
K102893Device Name
PCP/PC STETHOSCOPE
Manufacturer
RNK PRODUCTS, INC.
Date Cleared
2011-01-20
(112 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
RNK PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RNK PCP/PC Stethoscope is intended for use as a remote monitoring device, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on the IP network with the signal carried on an IP connection between the two locations.
The RNK PCP/PC Stethoscope is intended to transmit auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient at a different location on an IP network with the signal carried on an IP connection between the two locations.
Device Description
The PCP/PC Stethoscope is comprised of a PCP/PC Chest Piece that plugs into a generic PC on an IP network (e.g. the Internet) and the streaming Stethoscope Over IP (sSOIP) software application running on the PC. It provides remote auscultation between a patient at one location and a clinician at another location.
The PCP/PC Chest Piece derives operating voltage from the bias voltage on the Microphone port of the PC. PCP/PC Chest Piece contains an embedded amplifier which amplifies the auscultation signal from the piezo sensor and presents it as an analog signal to the Microphone input of the PC.
Under direction of the sSOIP program, the analog signal is digitized in the PC, formatted and converted to IP packets for transport. At the receive end PC, the sSOIP program directs the acceptance of the IP packets, conversion of the signal back to analog and presentation of the analog signal to the Headset port of the PC.
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K Number
K081032Device Name
TR-USB TELEPHONIC STETHOSCOPE
Manufacturer
RNK PRODUCTS, INC.
Date Cleared
2008-06-06
(56 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
RNK PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RNK Telephonic Stethoscope Model TR-USB is intended for use to transmit auscultation sounds, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communications channel between the two locations.
The RNK Telephonic Stethoscope Model TR-USB is intended for use as remote monitoring device, whereby a clinician at one location can listen to the auscultation sounds of a patient at a different location with the signal carried over a data communication channel between the two locations.
Device Description
The RNK Telephonic Stethoscope Model TR-USB consists of a Chest Piece Assembly, a standard audio Headset and an electronics Module containing amplifiers, filters, CODEC, UART and communication interface. The Chest Piece Assembly and Headset are detachable and can plug into the electronics Module. The electronics Module is capable of operating as a transmitting unit sending digitized auscultation signals from the attached Chest Piece, or as a receiving unit accepting the digitized auscultation signals, converting them to analog audio and presenting them to the attached Headset.
The communication interface to the RNK Telephonic Stethoscope is a standard USB data interface to a PC with a data communication channel.
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K Number
K072026Device Name
RNK ELECTRONIC STETHOSCOPE
Manufacturer
RNK PRODUCTS, INC.
Date Cleared
2007-10-26
(94 days)
Product Code
DQD, DOD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
RNK PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RNK Electronic Stethoscope is intended for use in detecting and amplifying heart, lung and other body sounds for diagnostic or monitoring purposes on any patient undergoing a physical assessment.
Device Description
The RNK Electronic Stethoscope is comprised of a Chest Piece assembly, an Amplifier module containing an amplifier, and a standard audio Headset. The Chest Piece assembly and Headset are detachable and can plug into the Amplifier module. The Amplifier module amplifies and filters the signal from the Chest Piece and presents it to the attached Headset. A standard 3.5 mm audio cable is used to connect the RNK Chest Piece Assembly to the RNK Amplifier. A standard, off-the-shelf Headset with a 3.5 mm plug can plug into the RNK Amplifier to enable a listener to hear the sounds from the RNK Chest Piece. The RNK Amplifier is powered by x2 AAA batteries, which can be easily accessed for replacement. Unplugging the RNK Chest Piece puts the Amplifier into low power mode. The RNK Electronic Stethoscope provides up to about 20 times greater amplitude signal than a typical acoustic stethoscope. The overall auscultation frequency response of the RNK Electronic Stethoscope is 20 Hz - 1,500 Hz.
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