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510(k) K945873

HYPEX(TM) JET INJECTOR by Equidyne Systems, Inc. — Product Code KZE

K945873 is an FDA 510(k) premarket notification submitted by Equidyne Systems, Inc. for the device "HYPEX(TM) JET INJECTOR". The FDA issued a decision of Substantially Equivalent on August 18, 1995. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. Equidyne Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1995
Date Received
December 1, 1994
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 Equidyne Systems, Inc.

  • K022502 — INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 (September 5, 2002)
  • K022148 — INJEX 30 NEEDLE FREE INJECTION SYSTEM (July 23, 2002)
  • K003741 — JET SYRINGE MODEL-100500 (June 1, 2001)
  • K003864 — INJEX 50 SYSTEM (March 6, 2001)

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