FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 561 C-ARM PROCEDURES STRETCHER
K Number: K923730
·
Decision Feb 9, 1994
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
49
Applicant Total
31
Review Days
562
Basic Information
- Device Name
- MODEL 561 C-ARM PROCEDURES STRETCHER
- K Number
- K923730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MIDMARK CORP.
- Date Received
- July 27, 1992
- Decision Date
- February 9, 1994
- Product Code
- FPO
- 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 |
|---|---|---|---|
| FPO | Stretcher, Wheeled | FDA class 2 | General Hospital |
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