ENGINEERED MEDICAL SYSTEMS INC

Address:3325 Appling Rd,Bartlett,TN,38133,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

Ventilator, Non-Continuous (Respirator) (BZD) (5) Attachment, Breathing, Positive End Expiratory Pressure (BYE) (2)

Premarket Exempt

No Yes

Clear

Whisper Soft - 00841470107895 Catalog Number :

Device Class : 2

Duns Number: 154502934

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Whisper Soft - 00841470107901 Catalog Number :

Device Class : 2

Duns Number: 154502934

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Whisper Soft - 00841470107918 Catalog Number :

Device Class : 2

Duns Number: 154502934

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SealFlex - 00841470108175 Catalog Number :

Device Class :

Duns Number: 154502934

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SealFlex - 00841470108182 Catalog Number :

Device Class :

Duns Number: 154502934

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AccuPAP - 00841470108212 Catalog Number :

Device Class : 2

Duns Number: 154502934

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

AccuPAP - 00841470108229 Catalog Number :

Device Class : 2

Duns Number: 154502934

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

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