EINSTEIN ASSOCIATES LLC

EINSTEIN ASSOCIATES LLC

Address:10101 Stafford Centre Drive Suite B,Stafford,TX,77477,US

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Filters

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) (10)

Premarket Exempt

No Yes

Clear

Zacurate - 00856964007001 Catalog Number : M430N-PDWH-CMZA

Device Description : Fingertip Pulse Oximeter (300A)

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007018 Catalog Number : M430N-DLWH-CMZA

Device Description : Fingertip Pulse Oximeter (500E)

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007025 Catalog Number : M430N-AABL-LHZA

Device Description : Fingertip Pulse Oximeter (500BL)

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007032 Catalog Number : M430N-AABL-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007049 Catalog Number : M430N-AABK-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007056 Catalog Number : M430N-AAPK-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007063 Catalog Number : M430N-AAVO-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007070 Catalog Number : M430N-DLVO-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007087 Catalog Number : M430N-DLPK-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Zacurate - 00856964007094 Catalog Number : M430N-DLBK-JPZA

Device Description : Fingertip Pulse Oximeter

Device Class : 2

Duns Number: 080641505

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

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