510(k) K210112
- Device
- XChange Device, XChange System
- Applicant
- Pneuma Therapeutics, Inc.
- 510(k) number
- K210112
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-30
- Date received
- 2021-01-19
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- William Densel
- Address
- 4090 E Bujia Primera Tucson AZ US 85718 85718
FDA Registration Numbers
- 2221819
- 3005877899
- 9710602
- 3006061749
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Source Documents
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