The following data is part of a premarket notification filed by Smd Manufacturing, Llc with the FDA for Reddyport Niv Access Elbow.
| Device ID | K171827 |
| 510k Number | K171827 |
| Device Name: | ReddyPort NIV Access Elbow |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | SMD Manufacturing, LLC 2500 South State Street, Suite D224 Salt Lake City, UT 84115 |
| Contact | Rian Wendling |
| Correspondent | Rian Wendling SMD Manufacturing, LLC 2500 South State Street, Suite D224 Salt Lake City, UT 84115 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2018-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850001175002 | K171827 | 000 |