Data / Medical devices / Israel / Shahak-Tec Ltd.
Shahak-Tec Ltd.: FDA-registered device maker in Zichron Yaakov Haifa, Israel, 6 510(k) clearances
Shahak-Tec Ltd. is registered with the FDA (registration 3010223399) in Zichron Yaakov Haifa, Israel. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 4, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010223399
- Address
- 1, Avshalom Road POB 166, Zichron Yaakov Haifa, Israel, 3095101
- Owner or operator
- Shahak-Tec Ltd. (10042902)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 9, 2013
- Registered through
- 2026
- Brand names listed
- Breath Collection Kit, CAPNOLINE H O2 ADULT, FilterLine H Set, Adult/Pediatric, FilterLine Set, Adult Pediatric, FilterLine Set, Infant/Neonate, Smart CapnoLine Guardian, Smart CapnoLine Guardian LONG, Smart CapnoLine O2 Pediatric and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Drain, Tee (Water Trap) | BYH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gas, Collecting Vessel | KGK | 1 | Manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 4, 2010 | K093388 | SMART CAPNOLINE GUARDIAN | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| November 29, 2001 | K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| November 14, 2001 | K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| March 14, 2001 | K010024 | O2/CO2 NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980327 | MICROSTREAM FILTERLINE ICU | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
| April 16, 1998 | K980324 | MICROSTREAM FILLERLINE OR/EMS | CCK | Substantially Equivalent | Oridion Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Drain, Tee (Water Trap)
- All makers of Gas, Collecting Vessel
- All makers of Lubricant, Patient
Updated March 4, 2010. 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.