Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
FDA 510(k) clearance K180683 · decided 2018-11-07
Clearance details
- K-number
- K180683
- Device name
- Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
- Applicant
- Certa Dose, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-15
- Decision date
- 2018-11-07
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- PQX
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Certa Dose
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 |
|---|---|---|
| Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe (K160589) | Certa Dose, Inc. | 2017-01-19 |
Recalls involving this device
No recalls on record reference this clearance.