Data / Medical devices / Mexico / Integrated Cable Assembly Holdings Sa De Cv
Integrated Cable Assembly Holdings Sa De Cv: FDA-registered device maker in Nogales Sonora, Mexico, 1 510(k) clearance
Integrated Cable Assembly Holdings Sa De Cv is registered with the FDA (registration 3012086037) in Nogales Sonora, Mexico. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 2, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012086037
- Address
- Boulevard del Raquet, #34, Nuevo, Nogales Sonora, Mexico, 84094
- Owner or operator
- ICA NORTHEAST, Inc. (10088499)
- Roles
- Repackager or relabeler
- First device listed
- August 2, 2023
- Registered through
- 2026
- Brand names listed
- Draeger Warmer Infant Radiant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Warmer, Infant Radiant | FMT | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 2, 2012 | K120642 | RESUSCITAIRE WITH AUTOBREATH | FMT | Substantially Equivalent | Draeger Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 2, 2012. 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.