EleGARD
Board, Cardiopulmonary
AdvancedCPR Solutions LLC
The following data is part of a premarket notification filed by Advancedcpr Solutions Llc with the FDA for Elegard.
Pre-market Notification Details
| Device ID | K221901 |
| 510k Number | K221901 |
| Device Name: | EleGARD |
| Classification | Board, Cardiopulmonary |
| Applicant | AdvancedCPR Solutions LLC 5201 Eden Avenue Suite 300 Edina, MN 55436 |
| Contact | Philip Faris |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | FOA |
| CFR Regulation Number | 880.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-07-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B716DEVELG003 | K221901 | 000 |
Trademark Results [EleGARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELEGARD 88048084 not registered Live/Pending |
Minnesota Resuscitation Solutions LLC 2018-07-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.