Data / Medical devices / Israel / Hospitech Respiration
Hospitech Respiration: FDA-registered device maker in Lod Central IL, Israel, 5 510(k) clearances
Hospitech Respiration is registered with the FDA (registration 3007682555) in Lod Central IL, Israel. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 12, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007682555
- Address
- 1 Galil St. Airport City Industrial Zone, Lod Central IL, Israel, 701990
- Owner or operator
- Hospitech Respiration (10034108)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 5, 2010
- Registered through
- 2026
- Brand names listed
- AG Cuffill, AG100S, AnapnoGuard 100, AnapnoGuard Cuffill, AnapnoGuard ETT, AnapnoGuard MASS, Cuffill, MASS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Manufacturer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Dropper, Ether | BTP | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | 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 |
|---|---|---|---|---|---|---|
| October 12, 2018 | K180991 | AG 100s | BSK | Substantially Equivalent | Hospitech Respiration , Ltd. | accessdata.fda.gov |
| February 16, 2016 | K150157 | AnapnoGuard 100 Respiratory Guard System | BSK | Substantially Equivalent | Hospitech Respiration , Ltd. | accessdata.fda.gov |
| May 13, 2013 | K131099 | AG MASS | JCX | Substantially Equivalent | Hospitech Respiration , Ltd. | accessdata.fda.gov |
| May 3, 2013 | K122721 | AG GUFFILL | BSK | Substantially Equivalent | Hospitech Respiration , Ltd. | accessdata.fda.gov |
| March 2, 2010 | K093126 | ANAPNOGUARD ENDOTRACHEAL TUBE | BTP | Substantially Equivalent | Hospitech Respiration , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
Updated October 12, 2018. 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.