FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDNOVA SAFETY BAG
K Number: K853075
·
Decision Oct 16, 1985
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- MEDNOVA SAFETY BAG
- K Number
- K853075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mednova Corp.
- Date Received
- July 23, 1985
- Decision Date
- October 16, 1985
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Mednova Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854813 | MEDNOVA BLOOD PRESSURE CUFF | Jun 20, 1986 | Substantially Equivalent |