FDA Clearance

23 Feb. 09
 
LD Technology commitment to excellence in Medical bio sensors research has been confirmed today by the FDA authorizing the marketing of the:
 Electro Sensor Teck Model PEMS1


Regulatory Class II 510 K 083229
21 CFR 870.2300

Electro Sensor Teck Model PEMS1

 1. Pulse Oximeter:
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement
2.  Heart rate variability (HRV):
To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analyses of the input of the heart rate variability.
The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis.
The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the ES Teck software.
The device is intended use only for adult subjects (>20 years old)
This Oximeter is intended to be used in spot-checking (2 minutes)
The device is intended use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended use in support life and not for continuously monitoring
The system will be used only by a licensed practitioner.

Quick Links...

www.ldteck.com

Europe: www.softmedtechnology.com

www.eiscenters.com (Link to users and distributors)

Contact Information

Ld Technology:

Albert Maarek MD CEO Developer 
100 North Biscayne Blvd #500 Miami Fl 33132 1-866-505-5233
305-915-1399/305-594-2145
Fax 305-468-3956  albert.ldteck@gmail.com
Europe Rudy Maarek Rudy@eissoft.net 
Latin America Richard Clement MD richardclementmd@yahoo.com