510(k) K180683
- Device
- Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
- Applicant
- Certa Dose, Inc.
- 510(k) number
- K180683
- Product code
- PQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-07
- Date received
- 2018-03-15
- Regulation
- 880.5860
- Classification name
- Epinephrine Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Caleb Hernandez
- Address
- 7351 E Lowry Blvd. #400 Denver CO US 80230 80230
FDA Registration Numbers#
- 1220477
- 1225580
- 3020460367
- 3014759854
Source Documents#
Other 510(k) Records For Product Code PQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | Certa Dose, Inc. | 2017-01-19 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases