510(k) K161953
- Device
- ReDe Mask
- Applicant
- TereoPneuma
- 510(k) number
- K161953
- Product code
- PRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-17
- Date received
- 2016-07-18
- Regulation
- 868.2375
- Classification name
- Device Indicating An Exhalation Event
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Warren G. Young
- Address
- 13223 Black Mountain Rd., Suite 1-224 San Diego CA US 92129 92129
Source Documents
Legacy Summary
summary
FDA Review
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