FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOTI APRON
K Number: K810095
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- MOTI APRON
- K Number
- K810095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Moti Enterprises, Inc.
- Date Received
- January 14, 1981
- Decision Date
- February 12, 1981
- Product Code
- KPY
- 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 |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
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