NIHON SEIMITSU SOKKI CO., LTD.

Address:2508-13 NAKAGO,SHIBUKAWA Gunma,JP

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3)

Premarket Exempt

Clear

NISSEI - 04931140011334 Catalog Number :

Device Description : DSK-1011 is an upper arm type blood pressure monitor. This product is intended f DSK-1011 is an upper arm type blood pressure monitor. This product is intended for noninvasive measurement of systolic and diastolic blood pressure and pulse rate as well as calculation of pulse pressure in adults in a home healthcare environment. The product is not designed for neonatal use.Measurement is performed during the inflation of the cuff. The cuff is automatically inflated rapidly at the initial phase then gradually afterwards. The masurement ends as the systolic blood pressure is determined and then the measurement result is displayed. The initial rapid inflation value is set by the readings of the last three measurements by the function so-called Personal Mode. Other functions such as WHO Classification indication, Pulse Pressure display, Body Motion indicator, and Irregular Pulse Rhythm indicatcion are equipped. Up to 60 readings in 2 memory banks can be stored.

Device Class :

Duns Number: 690593702

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

NISSEI - 04931140011402 Catalog Number :

Device Description : DSK-1031 is an upper arm type blood pressure monitor. This product is intended f DSK-1031 is an upper arm type blood pressure monitor. This product is intended for noninvasive measurement of systolic and diastolic blood pressure and pulse rate as well as calculation of pulse pressure in adults in a home healthcare environment. The product is not designed for neonatal use.Measurement is performed during the deflation of the cuff. The cuff is automatically inflated rapidly to the pressure value sufficiently above the systolic value before it shifts to the gradual deflation for measurement. The masurement ends after the diastolic blood pressure is determined and then the measurement result is displayed. Other functions such as WHO Classification indication, Pulse Pressure display, Body Motion indicator, Cuff Application check, and Irregular Pulse Rhythm indicatcion are equipped. Up to 60 readings in 2 memory banks can be stored.

Device Class :

Duns Number: 690593702

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

NISSEI - 04931140061018 Catalog Number :

Device Description : WSK-1011 is a wrist type blood pressure monitor. This product is intended for no WSK-1011 is a wrist type blood pressure monitor. This product is intended for noninvasive measurement of systolic and diastolic blood pressure and pulse rate as well as calculation of pulse pressure in adults in a home healthcare environment. The product is not designed for neonatal use.Measurement is performed during the deflation of the cuff. The cuff is automatically inflated rapidly to the pressure value sufficiently above the systolic value before it shifts to the gradual deflation for measurement. The masurement ends after the diastolic blood pressure is determined and then the measurement result is displayed. Other functions such as WHO Classification indication, Pulse Pressure display, Body Motion indicator, and Irregular Pulse Rhythm indicatcion are equipped. Up to 60 readings in 2 memory banks can be stored.

Device Class :

Duns Number: 690593702

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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