INJEX 50 SYSTEM— 510(k) K003864
Substantially EquivalentEquidyne Systems, Inc.
FDA 510(k) clearance K003864 for INJEX 50 SYSTEM, Substantially Equivalent on 2001-03-06. Applicant: Equidyne Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Equidyne Systems, Inc.
- Product code
- Code KZE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5430
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code KZE
view all- K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
- K111517 — PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
- K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
- K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
- K090003 — ZETAJET
More clearances from Equidyne Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.