FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BOMDAL STANDARD LIFT
K Number: K862147
·
Decision Jul 15, 1986
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
20
Applicant Total
2
Review Days
41
Basic Information
- Device Name
- BOMDAL STANDARD LIFT
- K Number
- K862147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5500
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- BOMDAL MEDICAL EQUIPMENT, INC.
- Date Received
- June 4, 1986
- Decision Date
- July 15, 1986
- Product Code
- FNG
- 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 |
|---|---|---|---|
| FNG | Lift, Patient, Ac-Powered | FDA class 2 | General Hospital |
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Other Clearances by BOMDAL MEDICAL EQUIPMENT, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K862146 | BOMDAL TRAVELMASTER LIFT | Jul 15, 1986 | Substantially Equivalent |