The following data is part of a premarket notification filed by Einstein Works, L.l.c with the FDA for Adult Intraosseous Infusion Device.
| Device ID | K182770 |
| 510k Number | K182770 |
| Device Name: | Adult Intraosseous Infusion Device |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Einstein Works, L.L.C 5312 Elm Street Houston, TX 77081 |
| Contact | Linda Taylor |
| Correspondent | David Makanani OMEDtech, LLC 1725 Signal Ridge Drive Suite 150 Edmond, OK 73013 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850026832034 | K182770 | 000 |