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) (4) Warmer, Infant Radiant (FMT) (4) Incubator, Neonatal Transport (FPL) (2)

Premarket Exempt

No Yes

Clear

V-707 with Power Pack(100-120V) - 04942962613057 Catalog Number : 61305

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FPL

Prescription Use : No

Device Count : 1

V-808 Main Unit Only(120 V) - 04942962615228 Catalog Number : 61522

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FPL

Prescription Use : No

Device Count : 1

Sunflower Warmer, Stand AC120V - 04942962615723 Catalog Number : 61572

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMT

Prescription Use : No

Device Count : 1

Sunflower Warmer, Wall Mount AC120V - 04942962615747 Catalog Number : 61574

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMT

Prescription Use : No

Device Count : 1

Sunflower Warmer, Stand AC120V - 04942962615761 Catalog Number : 61576

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMT

Prescription Use : No

Device Count : 1

Sunflower Warmer, Wall Mount AC120V - 04942962615778 Catalog Number : 61577

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMT

Prescription Use : No

Device Count : 1

Atom Infant Incubator 100 AC120V w/O2 Controller Unit - 04942962616003 Catalog Number : 61600

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Atom Infant Incubator 100 AC120V w/o O2 Controller Unit - 04942962616027 Catalog Number : 61602

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Atom Infant Incubator 101 AC120V w/O2 Controller Unit - 04942962616058 Catalog Number : 61605

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

Atom Infant Incubator 101 AC120V w/o O2 Controller Unit - 04942962616072 Catalog Number : 61607

Device Class : 2

Duns Number: 690632047

Premarket Exempt : No

Product Code : FMZ

Prescription Use : No

Device Count : 1

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