FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDAJET XL - JET INJECTOR
K Number: K850754
·
Decision Dec 10, 1985
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
52
Applicant Total
8
Review Days
288
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Basic Information
- Device Name
- MEDAJET XL - JET INJECTOR
- K Number
- K850754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5430
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mada Medical Products, Inc.
- Date Received
- February 25, 1985
- Decision Date
- December 10, 1985
- Product Code
- KZE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZE | Injector, Fluid, Non-Electrically Powered | FDA class 2 | General Hospital |
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Other Clearances by Mada Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003862 | MADA WHEELCHAIRS | Jan 12, 2001 | Substantially Equivalent |
| K002943 | WHEELCHAIR, MECHANICAL SERIES MODEL 3100 | Oct 23, 2000 | Substantially Equivalent |
| K950777 | OXYGEN REGULATOR | Apr 14, 1995 | Substantially Equivalent |
| K930949 | VOYAGE | Jun 1, 1993 | Substantially Equivalent |
| K930947 | PROMENADE | Jun 1, 1993 | Substantially Equivalent |
| K921611 | MADAVAC 190 | Sep 9, 1992 | Substantially Equivalent |
| K802426 | RESPO2 OXYGEN CONCENTRATOR | Oct 23, 1980 | Substantially Equivalent |