EleGARD Patient Positioning System
FDA 510(k) clearance K191689 · decided 2020-02-13
Clearance details
- K-number
- K191689
- Device name
- EleGARD Patient Positioning System
- Applicant
- Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio
- Decision
- Substantially Equivalent
- Date received
- 2019-06-25
- Decision date
- 2020-02-13
- Days to decision
- 233 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Minnesota Resuscitation Solutions
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EleGARD (K221901) | Advancedcpr Solutions, LLC | 2022-07-29 |
| ECA (K811397) | Gillco, Inc. | 1981-07-02 |
Recalls involving this device
No recalls on record reference this clearance.