Sigma Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
What Sigma Medical, Inc. makes
Sigma Medical, Inc. manufactures non-conductive anesthesia circuits and ventilator circuits, including pediatric and adult-sized designs with breath-bag attachments. These devices are intended for use in anesthesia delivery systems to ensure electrical isolation and prevent conductive hazards during surgical procedures. Some models include bacterial filtration to reduce contamination risk.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. These devices are intended for use in the United States and are subject to compliance with FDA requirements for electrical safety and performance in anesthesia circuits.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Sigma Medical, Inc. have in the registry?
The registry currently lists 13 devices for Sigma Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sigma Medical, Inc.'s devices?
Among its 13 most recently registered devices, Sigma Medical, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Sigma Medical, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Sigma Medical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sigma Medical, Inc. in the registry?
The most recently registered devices listed for Sigma Medical, Inc. include #3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG, 4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT, 3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W and 4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL.