510(k) K180683
K180683 is an FDA 510(k) premarket notification submitted by Certa Dose, Inc. for the device "Certa Dose Pediatric Midazolam 5mg/mL IM Syringe". The FDA issued a decision of Substantially Equivalent on Nov 7, 2018. The device falls under product code PQX (Epinephrine Syringe), a Class II device regulated under 21 CFR 880.5860. Certa Dose, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 7, 2018
- Date Received
- Mar 15, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Epinephrine Syringe
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)
Intended for intramuscular or subcutaneous injection of epinephrine.