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510(k) K864984

ROBINJECT by International Medical Products, Inc. — Product Code KZE

K864984 is an FDA 510(k) premarket notification submitted by International Medical Products, Inc. for the device "ROBINJECT". The FDA issued a decision of Substantially Equivalent on June 29, 1987. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. International Medical Products, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1987
Date Received
December 22, 1986
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 International Medical Products, Inc.

  • K981069 — ULTRA-COVER PU-TRANSDUCER COVER (September 23, 1998)
  • K981003 — ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES (June 16, 1998)
  • K973253 — ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (October 30, 1997)
  • K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE D (June 16, 1997)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K900755 — DIGITAL CUFF PV GAUGE (April 26, 1990)
  • K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (February 25, 1987)
  • K861539 — NIKKISO INFUSION PUMP MODEL PFA-02 (July 31, 1986)

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