FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DP 100
K Number: K911192
·
Decision Dec 11, 1991
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
57
Review Days
268
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Basic Information
- Device Name
- DP 100
- K Number
- K911192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Ferguson Medical
- Date Received
- March 18, 1991
- Decision Date
- December 11, 1991
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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| K972217 | ORTHOPEDIC SCREW SYSTEM | Nov 20, 1997 | Substantially Equivalent |
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| K970819 | TARGOBEAM | Jul 14, 1997 | Substantially Equivalent |
| K970280 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES | May 22, 1997 | Substantially Equivalent |
| K970258 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES | May 22, 1997 | Substantially Equivalent |
| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |