DeviceClearance

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe— 510(k) K180683

Substantially Equivalent

Certa Dose, Inc.

FDA 510(k) clearance K180683 for Certa Dose Pediatric Midazolam 5mg/mL IM Syringe, Substantially Equivalent on 2018-11-07. Applicant: Certa Dose, Inc.. Device class: 2.

Clearance details

Applicant
Certa Dose, Inc.
Product code
Code PQX
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Denver, CO, US
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