ECA
FDA 510(k) clearance K811397 · decided 1981-07-02
Clearance details
- K-number
- K811397
- Device name
- ECA
- Applicant
- Gillco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-18
- Decision date
- 1981-07-02
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- FOA
- Device class
- 1
- Regulation number
- 880.6080
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, 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 (K221901) | Advancedcpr Solutions, LLC | 2022-07-29 |
| EleGARD Patient Positioning System (K191689) | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | 2020-02-13 |
Recalls involving this device
No recalls on record reference this clearance.