EleGARD
FDA 510(k) clearance K221901 · decided 2022-07-29
Clearance details
- K-number
- K221901
- Device name
- EleGARD
- Applicant
- Advancedcpr Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-06-30
- Decision date
- 2022-07-29
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FOA
- Device class
- 1
- Regulation number
- 880.6080
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EleGARD Patient Positioning System (K191689) | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 2020-02-13 |
| ECA (K811397) | Gillco, Inc. | 1981-07-02 |
Recalls involving this device
No recalls on record reference this clearance.