Data / Medical devices / Canada / BLS Systems, Ltd.
BLS Systems, Ltd.: FDA-registered device maker in OAKVILLE Ontario, Canada, 6 510(k) clearances
BLS Systems, Ltd. is registered with the FDA (registration 9681848) in OAKVILLE Ontario, Canada. It lists 11 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681848
- FEI number
- 3000213164
- Address
- 1124 South Service RD. West, OAKVILLE Ontario, Canada, L6L 5T7
- Owner or operator
- BLS SYSTEMS, LTD. (9027719)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 3, 1996
- Registered through
- 2026
- Brand names listed
- AMBU RESCUE MASK, FLO2MAX Oxygen Mask, O-Mask Oxygen Mask, Rescuer, Rescuer BVM Resuscitator, Rescuer CPR Mask, Rescuer Emergency CPAP, Rescuer Emergency CPAP System and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 5, 2013 | K122610 | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | BYE | Substantially Equivalent | Sen MU Technology Co., Ltd. | accessdata.fda.gov |
| September 15, 2005 | K051260 | SCHUCO MIST AND SCHUCO DELUXE MIST | CAF | Substantially Equivalent | Allied Healthcare Products, Inc. | accessdata.fda.gov |
| March 14, 2001 | K010191 | Y2000 POCKET RESCUE | CBP | Substantially Equivalent | Cheen Houng Ent. Co. , Ltd. | accessdata.fda.gov |
| March 24, 2000 | K993194 | RUSCH MANUAL RESUSCITATOR BAG | BTM | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
| July 14, 1998 | K981415 | 0-20 CM H20 PEEP VALVE | BYE | Substantially Equivalent | Cheen Houng Ent. Co. , Ltd. | accessdata.fda.gov |
| October 3, 1996 | K954490 | MERCURY MEDICAL CPR BAG EXHALATION FILTER | CAH | Substantially Equivalent | Mercury Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Airway Suction Kit
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Catheters, Suction, Tracheobronchial
Updated August 5, 2013. 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.