Robert I. Chien & Assoc., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What Robert I. Chien & Assoc., Inc. makes
Robert I. Chien & Assoc., Inc. manufactures and represents surgical instruments, including RICA and SMIC brands, as well as diagnostic instruments under the RICA line. The company also produces thermometers and unsterilized laparotomy sponges, primarily sourced from China.
These products are regulated under FDA Class I and Class II classifications, with some devices requiring 510(k) clearance. The company’s instruments are listed in the FDA’s 510(k) registry, and the business is based in the United States.
Catalogue
Thermometer (Made In China) Ref K811631
510(k) 510(k)Rica Or Smic Surgical Instruments Ref K801028
510(k) 510(k)Rica (Diagnostic Instruments) Ref K810054
510(k) 510(k)Surgical Instruments Represent. 4 Class Ref K822151
510(k) 510(k)Surgical Instruments Ref K801819
510(k) 510(k)Unsterilized Laparotomy Sponges (China) Ref K811632
510(k) 510(k)
Frequently asked questions
How many devices does Robert I. Chien & Assoc., Inc. have in the registry?
The registry currently lists 6 devices for Robert I. Chien & Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Robert I. Chien & Assoc., Inc.'s devices?
Among its 6 most recently registered devices, Robert I. Chien & Assoc., Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Robert I. Chien & Assoc., Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Robert I. Chien & Assoc., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Robert I. Chien & Assoc., Inc. in the registry?
The most recently registered devices listed for Robert I. Chien & Assoc., Inc. include THERMOMETER (MADE IN CHINA), RICA OR SMIC SURGICAL INSTRUMENTS, RICA (DIAGNOSTIC INSTRUMENTS) and SURGICAL INSTRUMENTS REPRESENT. 4 CLASS.