MEDICAL TEST SUPPLY

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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 (DQA) (5) Oximeter, Infrared, Sporting, Aviation (OCH) (1)

Premarket Exempt

Clear

MTS - 00869667000408 Catalog Number : OX610A

Device Description : The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxy The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (Spo2) and pulse rate (PR). It is motion tolerant and can be used during exercise and other daily activities.

Device Class : 2

Duns Number: 064063916

Premarket Exempt : No

Product Code : OCH

Prescription Use : No

Device Count : 1

MTS - 00869667000415 Catalog Number : OX400A

Device Description : The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and puls The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing, providing fast and accurate oximetry measurements.

Device Class : 2

Duns Number: 064063916

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

MTS - 00869667000422 Catalog Number : OX300A

Device Description : The OX-300A Finger Pulse Oximeter will display oxygen saturation (Spo2) and puls The OX-300A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing and providing fast and accurate measurements.

Device Class : 2

Duns Number: 064063916

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

MTS - 00869667000439 Catalog Number : OX200A

Device Description : The OX-200A Finger Pulse Oximeter will display oxygen saturation (Spo2) and puls The OX-200A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing and providing fast and accurate measurements. This device is splash-proof and motion tolerant.

Device Class : 2

Duns Number: 064063916

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

MTS - 00869667000446 Catalog Number : OX550AP

Device Description : The OX-550AP Pediatric Finger Pulse Oximeter will display oxygen saturation (Spo The OX-550AP Pediatric Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It is specifically designed for small fingers allowing for fast accurate oximetry results with pediatric users. It displays the perfusion index (PI) to help in selecting the best finger for testing.

Device Class : 2

Duns Number: 064063916

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

MTS - 00869667000453 Catalog Number : OX500A

Device Description : The OX-500A Finger Pulse Oximeter will display oxygen saturation (Spo2) and puls The OX-500A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It is a feature rich device with many programmable functions. Highly reliable with fast accurate measurements.

Device Class : 2

Duns Number: 064063916

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

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