FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAMM-AIRE
K Number: K863890
·
Decision Oct 14, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
1
Review Days
8
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Basic Information
- Device Name
- MAMM-AIRE
- K Number
- K863890
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1830
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Ar Custom Medical Products, Ltd.
- Date Received
- October 6, 1986
- Decision Date
- October 14, 1986
- Product Code
- KXH
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| KXH | Cradle, Patient, Radiologic | FDA class 1 | Radiology |
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