Atlas FDA

MED-E-JET INJECTOR

FDA 510(k) clearance K913018 · decided 1991-09-16

Clearance details

K-number
K913018
Device name
MED-E-JET INJECTOR
Applicant
Med-E-Jet D
Decision
Substantially Equivalent
Date received
1991-07-09
Decision date
1991-09-16
Days to decision
69 days
Clearance type
Traditional
Product code
KZE
Device class
2
Regulation number
880.5430
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Cleveland, OH, 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
ZETAJET (K090003)Bioject, Inc.2009-04-02
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

Recalls involving this device

No recalls on record reference this clearance.