FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDO MEDOMER MBF-100 II
K Number: K841235
·
Decision Nov 19, 1984
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
2
Review Days
242
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Basic Information
- Device Name
- MEDO MEDOMER MBF-100 II
- K Number
- K841235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medo U.S.A., Inc.
- Date Received
- March 22, 1984
- Decision Date
- November 19, 1984
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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Other Clearances by Medo U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844064 | MEDO BUBBLE BATH MA-80, 400, 600 & 700 | Jan 23, 1985 | Substantially Equivalent |