C.L. Mcintosh & Assoc., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What C.L. Mcintosh & Assoc., Inc. makes
C.L. McIntosh & Assoc., Inc. manufactures ultrasound diathermy devices, including the DUO-SON ULTRASOUND DIATHERMY DEVICE, for therapeutic applications. Their portfolio also includes the NICAS 2001, a noninvasive system for monitoring cardiorespiratory function. Additionally, they produce the AUTIMO 2.5-D and AUTIMO 3-D imaging systems, as well as the OSCAR Orthosonics System for cemented arthroplasty revision procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, where the manufacturer is based.
Catalogue
Orthosonics Duo-Son Ultrasound Diathermy Device Ref K970131
510(k) 510(k)Nicas 2001 Noninvasive Cardio-Respiratory System Ref K942227
510(k) 510(k)Autimo 2.5-D And Autimo 3-D Ref K972016
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does C.L. Mcintosh & Assoc., Inc. have in the registry?
The registry currently lists 4 devices for C.L. Mcintosh & Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list C.L. Mcintosh & Assoc., Inc.'s devices?
Among its 4 most recently registered devices, C.L. Mcintosh & Assoc., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do C.L. Mcintosh & Assoc., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for C.L. Mcintosh & Assoc., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from C.L. Mcintosh & Assoc., Inc. in the registry?
The most recently registered devices listed for C.L. Mcintosh & Assoc., Inc. include ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE, NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM, AUTIMO 2.5-D AND AUTIMO 3-D and OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION.