Fraser Harlake, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Fraser Harlake, Inc. makes
Fraser Harlake, Inc. manufactures medical devices for anesthesia, emergency care, and respiratory support, including continuous flow vaporizers for inhalation anesthesia, nitrous oxide scavenger systems, and powered emergency ventilators. Their portfolio also includes devices for monitoring blood pressure, such as sphygmomanometers, and positive pressure valves for respiratory therapy. Emergency care solutions like suction systems and resuscitation devices are also part of their product line, alongside anesthesia gas machines and dental anti-pollution systems.
The company’s devices are classified under Class II in the US and are listed via FDA 510(k) clearance. Their products are regulated under the US Food and Drug Administration’s medical device framework, ensuring compliance with safety and performance standards for active and special controls. The company is headquartered in the United States.
Catalogue
Cyprane Tec 4 Continuous Flow Vapor. Ref K831427
510(k) 510(k)Fraser Harlake Nitronox Scavenger Ref K821744
510(k) 510(k)Sphygomano Meter Ref K833799
510(k) 510(k)Positive End Expiratory Pressure Valve Ref K802943
510(k) 510(k)Fraser Harlake Hope Iii Resuscitator Ref K841496
510(k) 510(k)Powered Emergency Ventilator Ref K822040
510(k) 510(k)Boyle System Anesthesia Gas Machine Ref K833151
510(k) 510(k)Fraser Harlake Dental Anti-Polution Sys Ref K833692
510(k) 510(k)Fraser Harlake Emerg. Care Suction Sys Ref K841903
510(k) 510(k)
Frequently asked questions
How many devices does Fraser Harlake, Inc. have in the registry?
The registry currently lists 9 devices for Fraser Harlake, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fraser Harlake, Inc.'s devices?
Among its 9 most recently registered devices, Fraser Harlake, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Fraser Harlake, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Fraser Harlake, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fraser Harlake, Inc. in the registry?
The most recently registered devices listed for Fraser Harlake, Inc. include CYPRANE TEC 4 CONTINUOUS FLOW VAPOR., FRASER HARLAKE NITRONOX SCAVENGER, SPHYGOMANO METER and POSITIVE END EXPIRATORY PRESSURE VALVE.