CETRO AMERICA INC

Address:801 N Main Street Ext,Wallingford,CT,06492,US

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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

System, Monitoring, Perinatal (HGM) (10)

Premarket Exempt

Clear

Cetro America Ultrasound Transducer for HP8040, Waterproof - 00852519007113 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer for HP8040 model fetal monitors.

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer for Coro 116, Waterproof - 00852519007120 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer for Corometrics 116 (including all Replacement Waterproof Ultrasound Transducer for Corometrics 116 (including all subsequent Corometrics models).

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer for FC6/8, FS6/8/10, Kranzbüler, Waterproof - 00852519007137 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer for FC6/8, FS6/8/10, Kranzbüler mod Replacement Waterproof Ultrasound Transducer for FC6/8, FS6/8/10, Kranzbüler model fetal monitors.

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer for Fetacare, Kranzbüler, Waterproof - 00852519007144 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer for Kranzbüler Fetacare fetal monitors.

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer for Coro 115&145, Waterproof - 00852519007151 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer for Corometrics 115&145 model fetal monitors.

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer 2 Mhz for Oxford SonicAid - 00852519007168 Catalog Number :

Device Description : Replacement Ultrasound Transducer 2 Mhz for Oxford SonicAid

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer 1.5 Mhz for Oxford SonicAid - 00852519007175 Catalog Number :

Device Description : Replacement Ultrasound Transducer 1.5 Mhz for Oxford SonicAid

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer 1.5 Mhz for Oxford SonicAid, Waterproof - 00852519007182 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer 1.5 Mhz for Oxford SonicAid

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer 2 Mhz for Oxford SonicAid, Waterproof - 00852519007199 Catalog Number :

Device Description : Replacement Waterproof Ultrasound Transducer 2 Mhz for Oxford SonicAid

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer 1.5 Mhz for Sonomed - 00852519007205 Catalog Number :

Device Description : Replacement Ultrasound Transducer 1.5 Mhz for Sonomed

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

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