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 US Transducer for IM76/AM66 - 00852519007007 Catalog Number :

Device Description : Replacement ultrasound transducer for Advanced Medical Systems IM76/AM66 model f Replacement ultrasound transducer for Advanced Medical Systems IM76/AM66 model fetal monitor.

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer for IM77/AM67 - 00852519007014 Catalog Number :

Device Description : Replacement ultrasound transducer for Advanced Medical Systems/SpaceLabs medical Replacement ultrasound transducer for Advanced Medical Systems/SpaceLabs medical IM77/AM67 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 HP8040 - 00852519007038 Catalog Number :

Device Description : Replacement 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 - 00852519007045 Catalog Number :

Device Description : Ultrasounds Transducer for Corometrics 116 model fetal monitor including all sub Ultrasounds Transducer for Corometrics 116 model fetal monitor 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 - 00852519007052 Catalog Number :

Device Description : Ultrasound Transducer for Kranzbüler FC6/8, FS6/8/10 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 - 00852519007069 Catalog Number :

Device Description : Ultrasound Transducer for Kranzbüler Fetacare 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 Corometrics 115 & 145 - 00852519007076 Catalog Number :

Device Description : 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 for IM76/AM66, Waterproof - 00852519007083 Catalog Number :

Device Description : Waterproof Ultrasound Transducer for Advanced Medical Systems/SpaceLabs medical Waterproof Ultrasound Transducer for Advanced Medical Systems/SpaceLabs medical IM76/AM66 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 IM77/AM67, Waterproof - 00852519007090 Catalog Number :

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Cetro America Ultrasound Transducer for HP1350, Waterproof - 00852519007106 Catalog Number :

Device Description : Waterproof Ultrasound Transducer for HP1350, (including all subsequent Philips models).

Device Class : 2

Duns Number: 196275197

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

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