FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MEDEBAR XL
K Number: K800844
·
Decision May 30, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
7
Applicant Total
6
Review Days
45
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Basic Information
- Device Name
- MEDEBAR XL
- K Number
- K800844
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Medefield Pty. , Ltd.
- Date Received
- April 15, 1980
- Decision Date
- May 30, 1980
- Product Code
- KTA
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KTA | Medium, Contrast, Radiologic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTA), ordered by most recent decision date.
MEDEFIZZ A & MEDEFIZZ B
FDA 510(k)
FDA Unclassified
·Unknown
MEDEFOAM-2
FDA 510(k)
FDA Unclassified
·Unknown
MEDEBAR M
FDA 510(k)
FDA Unclassified
·Unknown
MEDEBAR XAC-90
FDA 510(k)
FDA Unclassified
·Unknown
MEDESCAN
FDA 510(k)
FDA Unclassified
·Unknown
BARIUM SULFATE, USP IN SUSPENSION
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Medefield Pty. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K800843 | MEDEFIZZ A & MEDEFIZZ B | Jun 17, 1980 | Substantially Equivalent |
| K800840 | MEDEFOAM-2 | Jun 17, 1980 | Substantially Equivalent |
| K800841 | MEDEBAR M | May 30, 1980 | Substantially Equivalent |
| K800842 | MEDEBAR XAC-90 | May 30, 1980 | Substantially Equivalent |
| K800839 | MEDESCAN | May 30, 1980 | Substantially Equivalent |