Fraser Sweatman, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Fraser Sweatman, Inc. makes
Fraser Sweatman, Inc. manufactures medical devices for anesthesia, patient ventilation, and spinal immobilization, including reusable and disposable systems. Their portfolio includes double masks for patient ventilation, pre-set gas mixers for nitrous oxide and oxygen, CO₂ absorbers for anesthesia circuits, emergency oxygen resuscitators, and cervical collars for spinal stabilization. The company also produces lifting frames designed for patient transfer and positioning.
The company’s devices are regulated under FDA Class I and Class II classifications, with several products cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Fraser Sweatman's Double Mask Ref K761140
510(k) 510(k)Pre-Set 50/50 Nitrous Oxide/Oxygen Mixer Ref K760766
510(k) 510(k)Absorber, Anesthesia Circle Sys, CO2 Ref K760076
510(k) 510(k)Emergency Oxygen Resuscitator Ref K771299
510(k) 510(k)Medishield Cervical Collar Ref K770910
510(k) 510(k)Medishield Jordon Lifting Frame Ref K770911
510(k) 510(k)
Frequently asked questions
How many devices does Fraser Sweatman, Inc. have in the registry?
The registry currently lists 6 devices for Fraser Sweatman, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fraser Sweatman, Inc.'s devices?
Among its 6 most recently registered devices, Fraser Sweatman, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Fraser Sweatman, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Fraser Sweatman, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fraser Sweatman, Inc. in the registry?
The most recently registered devices listed for Fraser Sweatman, Inc. include FRASER SWEATMAN'S DOUBLE MASK, PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER, ABSORBER, ANESTHESIA CIRCLE SYS, CO2 and EMERGENCY OXYGEN RESUSCITATOR.