Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
FDA 510(k) clearance K160589 · decided 2017-01-19
Clearance details
- K-number
- K160589
- Device name
- Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
- Applicant
- Certa Dose, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-01
- Decision date
- 2017-01-19
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- PQX
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dever, CO, 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 |
|---|---|---|
| Certa Dose Pediatric Midazolam 5mg/mL IM Syringe (K180683) | Certa Dose, Inc. | 2018-11-07 |
Recalls involving this device
No recalls on record reference this clearance.