FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOEHRINGER MRI SUCTION REGULATORY
K Number: K013976
·
Decision Jan 8, 2002
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
20
Applicant Total
38
Review Days
36
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Basic Information
- Device Name
- BOEHRINGER MRI SUCTION REGULATORY
- K Number
- K013976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boehringer Laboratories
- Date Received
- December 3, 2001
- Decision Date
- January 8, 2002
- Product Code
- KDP
- 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 |
|---|---|---|---|
| KDP | Regulator, Vacuum | FDA class 2 | General Hospital |
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