Spica, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Spica, Inc. makes
Spica, Inc. manufactures medical gas delivery systems, including manifold kits for connecting multiple gas sources, oxygen/nitrous oxide outlet valves, and standalone analgesia units designed for controlled administration of oxygen and nitrous oxide mixtures.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the U.S. regulatory database and comply with applicable U.S. medical device standards.
Catalogue
Manifold Kit Ref K780364
Regimes: 510(k) Registry: 510(k)Oxygen/Nitrous Oxide Outlet Ref K780365
Regimes: 510(k) Registry: 510(k)Analgesia Units, Oxygen & Nitrate Device Ref K800801
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spica, Inc. have in the registry?
The registry currently lists 3 devices for Spica, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spica, Inc.'s devices?
Among its 3 most recently registered devices, Spica, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Spica, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Spica, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spica, Inc. in the registry?
The most recently registered devices listed for Spica, Inc. include MANIFOLD KIT, OXYGEN/NITROUS OXIDE OUTLET and ANALGESIA UNITS, OXYGEN & NITRATE DEVICE.