Atlas FDA

ZETAJET

FDA 510(k) clearance K090003 · decided 2009-04-02

Clearance details

K-number
K090003
Device name
ZETAJET
Applicant
Bioject, Inc.
Decision
Substantially Equivalent
Date received
2009-01-02
Decision date
2009-04-02
Days to decision
90 days
Clearance type
Abbreviated
Product code
KZE
Device class
2
Regulation number
880.5430
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Tualatin, OR, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (K121270)Bioject Medical Technologies, Inc.2012-07-19
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI (K111517)Pharmajet, Inc.2011-07-27
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (K110456)Pharmajet, Inc.2011-03-02
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (K090959)D'Antonio Consultants International, Inc. (Dci)2009-12-24
PHARMAJET NEEDLE-FREE INJECTION SYSTEM (K081532)Pharmajet, Inc.2009-02-26
AIRGENT, MODEL AG7000010 (K082138)Perfaction, Inc.2009-01-23
COOL.CLICK 2 (K060819)Medical House Products Limited2006-06-16
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (K051985)Biovalve Technologies, Inc.2005-08-17
COOL.CLICK (K050734)Bioject, Inc.2005-06-03
GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (K041239)Genesis Medical Technology, Inc.2004-11-08
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 (K041280)Felton International, Inc.2004-06-24
BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001 (K032976)Biovalve Technologies, Inc.2004-04-16

Recalls involving this device

RecordFirmDate
Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lak recall (Z-1541-2012)CaridianBCT, Inc.2012-05-11