Data / Medical devices / Israel / Micro BVM Systems Ltd.
Micro BVM Systems Ltd.: FDA-registered device maker in Jerusalem, Israel, 1 510(k) clearance
Micro BVM Systems Ltd. is registered with the FDA (registration 3008264081) in Jerusalem, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 5, 2010. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008264081
- Address
- 11/3 Rozin St., Jerusalem, Israel, 93870
- Owner or operator
- MICRO BVM SYSTEMS (10031790)
- Roles
- Manufacturer
- First device listed
- March 9, 2010
- Registered through
- 2027
- Brand names listed
- Cyclone Pocket BVM, Cyclone Pocket BVM 1000, Pocket BVM, Pocket BVM NuMask, Pocket BVM O2 tubing 1000, Pocket BVM Tactical, Pocket BVM airway, Pocket BVM with O2 Tubing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 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 |
|---|---|---|---|---|---|---|
| February 5, 2010 | K093081 | POCKET BVM | BTM | Substantially Equivalent | Microbvm Systems , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 5, 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.