San Diego Plastics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What San Diego Plastics, Inc. makes
San Diego Plastics, Inc. manufactures respiratory oxygen delivery devices, including oxygen connecting tubesets and nebulizer systems like the N.E.W. NEB. These products are designed for use in medical settings to administer oxygen therapy and aerosolized medications.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway. Devices are regulated under US jurisdiction, with compliance managed through the FDA’s regulatory framework.
Catalogue
Oxygen Connecting Tubeset-Respiratory Ref K832660
Regimes: 510(k) Registry: 510(k)N.E.W. Neb Ref K830527
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does San Diego Plastics, Inc. have in the registry?
The registry currently lists 2 devices for San Diego Plastics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list San Diego Plastics, Inc.'s devices?
Among its 2 most recently registered devices, San Diego Plastics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do San Diego Plastics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for San Diego Plastics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from San Diego Plastics, Inc. in the registry?
The most recently registered devices listed for San Diego Plastics, Inc. include OXYGEN CONNECTING TUBESET-RESPIRATORY and N.E.W. NEB.