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510(k) K962625

VITAJET by Vitajet Corp. — Product Code KZE

K962625 is an FDA 510(k) premarket notification submitted by Vitajet Corp. for the device "VITAJET". The FDA issued a decision of Substantially Equivalent on December 10, 1996. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. Vitajet Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
July 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

Other clearances by Vitajet Corp.

  • K945548 — MEDIVAX (November 20, 1995)
  • K924447 — VITAPEN (September 27, 1993)

Other clearances for product code KZE

  • K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (July 19, 2012)
  • K111517 — PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJE (July 27, 2011)
  • K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (March 2, 2011)
  • K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (December 24, 2009)
  • K090003 — ZETAJET (April 2, 2009)
  • K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM (February 26, 2009)
  • K082138 — AIRGENT, MODEL AG7000010 (January 23, 2009)
  • K060819 — COOL.CLICK 2 (June 16, 2006)
  • K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (August 17, 2005)
  • K050734 — COOL.CLICK (June 3, 2005)

FDA data resources