APPLE INC.

APPLE INC.

Address:One Apple Park Way,Cupertino,CA,95014,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

Photoplethysmograph Analysis Software For Over-The-Counter Use (QDB) (6) Electrocardiograph Software For Over-The-Counter Use (QDA) (4)

Premarket Exempt

No Yes

Clear

Irregular Rhythm Notifications - 00190198909510 Catalog Number :

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDB

Prescription Use : No

Device Count : 1

Irregular Rhythm Notifications - 00190198909527 Catalog Number :

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDB

Prescription Use : No

Device Count : 1

ECG App - 00190198909534 Catalog Number :

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDA

Prescription Use : No

Device Count : 1

ECG App - 00190198909541 Catalog Number :

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDA

Prescription Use : No

Device Count : 1

ECG 2.0 App - 00190199649286 Catalog Number :

Device Description : ECG Watch App (version 2.0)

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDA

Prescription Use : No

Device Count : 1

ECG 2.0 App - 00190199649293 Catalog Number :

Device Description : ECG iPhone App (version 2.0)

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDA

Prescription Use : No

Device Count : 1

Irregular Rhythm Notification feature 2.0 - 00194252456774 Catalog Number :

Device Description : Irregular Rhythm Notification feature Watch App (Version 2.0)

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDB

Prescription Use : No

Device Count : 1

Irregular Rhythm Notification feature 2.0 - 00194252456781 Catalog Number :

Device Description : Irregular Rhythm Notification feature iPhone App (Version 2.0)

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDB

Prescription Use : No

Device Count : 1

Atrial Fibrillation History Feature - 00194252456798 Catalog Number :

Device Description : Atrial Fibrillation History Feature iPhone app

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDB

Prescription Use : No

Device Count : 1

Atrial Fibrillation History Feature - 00194252456804 Catalog Number :

Device Description : Atrial Fibrillation History Feature Watch app

Device Class : 2

Duns Number: 060704780

Premarket Exempt : No

Product Code : QDB

Prescription Use : No

Device Count : 1

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