ATOM MEDICAL CORPORATION

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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

Incubator, Neonatal (FMZ) (5) Ventilator, Emergency, Powered (Resuscitator) (BTL) (3) Mixer, Breathing Gases, Anesthesia Inhalation (BZR) (2)

Premarket Exempt

No Yes

Clear

Skin Temp Probe, 5mm O.D.(Y) - 04942962608831 Catalog Number : 60883

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Dispo Skin Temp Probe(Y) (10 pcs/box) - 04942962608848 Catalog Number : 60884

Device Class :

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 10

Connecting Cable(Y) For Dispo Skin Temp Probe - 04942962608855 Catalog Number : 60885

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Dispo Skin Temp Probe(W) (10 pcs/box) - 04942962608909 Catalog Number : 60890

Device Class :

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 10

Connecting Cable(W) For Dispo Skin Temp Probe - 04942962608916 Catalog Number : 60891

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Resuscitation Unit 104 E type (Stand-alone type) - 04942962609821 Catalog Number : 60982

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Blender Unit P type - 04942962609913 Catalog Number : 60991

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Blender Unit E type - 04942962609920 Catalog Number : 60992

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Resuscitation Unit E type - 04942962609937 Catalog Number : 60993

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

Resuscitation Unit P type - 04942962609944 Catalog Number : 60994

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : BTL

Prescription Use : Yes

Device Count : 1

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