The following data is part of a premarket notification filed by Ventlab, Llc with the FDA for Safet T-piece Resuscitator.
| Device ID | K173373 |
| 510k Number | K173373 |
| Device Name: | SafeT T-Piece Resuscitator |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | Ventlab, LLC 2710 Northridge Drive NW - Suite A Grand Rapids, MI 49544 |
| Contact | Rob Yamashita |
| Correspondent | Rob Yamashita Ventlab, LLC 2710 Northridge Drive NW - Suite A Grand Rapids, MI 49544 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-27 |
| Decision Date | 2018-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483231807 | K173373 | 000 |
| 10889483231791 | K173373 | 000 |
| 10889483231784 | K173373 | 000 |
| 10889483231777 | K173373 | 000 |
| 10889483231760 | K173373 | 000 |
| 10889483231746 | K173373 | 000 |
| 10889483231739 | K173373 | 000 |