S. and H. Engineering, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What S. and H. Engineering, Inc. makes
S. and H. Engineering, Inc. manufactures medical devices including the BREAST TREATMENT AID M200, a device designed for post-surgical or therapeutic breast support, the 6 FRENCH CATHETER for medical drainage procedures, and the HEAD RETAINING DEVICE for patient positioning and stabilization during treatment or imaging.
The company’s portfolio consists of Class II devices, each authorised via the FDA’s 510(k) clearance process. These products are listed under U.S. regulatory requirements and are intended for use within the American healthcare system.
Catalogue
Breast Treatment Aid M200 Ref K962487
510(k) 510(k)6 French Catheter Ref K922564
510(k) 510(k)Head Retaining Device Ref K961467
510(k) 510(k)Breast Treatment Aid Ref K961170
510(k) 510(k)
Frequently asked questions
How many devices does S. and H. Engineering, Inc. have in the registry?
The registry currently lists 4 devices for S. and H. Engineering, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list S. and H. Engineering, Inc.'s devices?
Among its 4 most recently registered devices, S. and H. Engineering, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do S. and H. Engineering, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for S. and H. Engineering, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from S. and H. Engineering, Inc. in the registry?
The most recently registered devices listed for S. and H. Engineering, Inc. include BREAST TREATMENT AID M200, 6 FRENCH CATHETER, HEAD RETAINING DEVICE and BREAST TREATMENT AID.