Data / Medical devices / United States / Cetro America
Cetro America: FDA-registered device maker in Meriden, CT, United States, 2 510(k) clearances
Cetro America is registered with the FDA (registration 3004167720) in Meriden, CT, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 10, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004167720
- Address
- 33 Charles Street, Meriden, CT, United States, 06450
- Owner or operator
- CETRO AMERICA (9057995)
- Roles
- Specification developer
- First device listed
- December 28, 2007
- Registered through
- 2026
- Brand names listed
- TOCO Transducer Model 8032007, TOCO Transducer Model 8032008, TOCO Transducer Model 8032009, TOCO Transducer Model 8032010, TOCO Transducer Model 8032025, TOCO Transducer Model 8032026, ULTRASONIC Transducer Model 8031010, ULTRASONIC Transducer Model 8031011 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | 2 | Specification developer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2006 | K050826 | FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS | HGM | Substantially Equivalent | Cetro America | accessdata.fda.gov |
| July 11, 1991 | K911657 | FETAL SCALP SPIRAL ELECTRODE | HGP | Substantially Equivalent | Advanced Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Circular (Spiral), Scalp And Applicator
- All makers of System, Monitoring, Perinatal
Updated April 10, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.