The following data is part of a premarket notification filed by Minnesota Resuscitation Solutions, D.b.d Advancedcpr Solutio with the FDA for Elegard Patient Positioning System.
| Device ID | K191689 |
| 510k Number | K191689 |
| Device Name: | EleGARD Patient Positioning System |
| Classification | Board, Cardiopulmonary |
| Applicant | Minnesota Resuscitation Solutions, D.b.d AdvancedCPR Solutio 5201 Eden Ave., Suite 300 Edina, MN 55436 |
| Contact | Philip Tetzlaff |
| Correspondent | Paul Dryden Minnesota Resuscitation Solutions, D.b.d AdvancedCPR Solutio 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | FOA |
| CFR Regulation Number | 880.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B716DEVELG002 | K191689 | 000 |