GOLDEN SMART HOME TECHNOLOGY CORP.

Address:Room 206, No.47, Yuanqu 2nd Rd.,Hsinchu City Hsinchu (City),TW

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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

Oximeter, Infrared, Sporting, Aviation (OCH) (1)

Premarket Exempt

No Yes

Clear

WowGoHealth Pulse Oximeter GSH601 - 04719878124027 Catalog Number : Orange

Device Description : The pulse oximeter is a reusable device, and it’s intended for intermittent chec The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.

Device Class :

Duns Number: 656002163

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

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