FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K Number: K061788
·
Decision Jul 11, 2006
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
37
Review Days
15
Basic Information
- Device Name
- BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
- K Number
- K061788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BOEHRINGER LABORATORIES
- Date Received
- June 26, 2006
- Decision Date
- July 11, 2006
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by BOEHRINGER LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K060277 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM | Mar 3, 2006 | Substantially Equivalent |
| K020538 | BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES | May 15, 2002 | Substantially Equivalent |
| K014187 | AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM | Feb 6, 2002 | Substantially Equivalent |
| K013976 | BOEHRINGER MRI SUCTION REGULATORY | Jan 8, 2002 | Substantially Equivalent |
| K955010 | AUTOVAC BP SYSTE, 2000 SERIES | Jun 20, 1996 | Substantially Equivalent |
| K945775 | BOEHRINGER AUTOVAC(R) 7900 SERIES | Oct 19, 1995 | Substantially Equivalent |
| K932093 | AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S | Jul 6, 1994 | Substantially Equivalent |
| K933232 | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | Mar 28, 1994 | Substantially Equivalent |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Feb 22, 1994 | Substantially Equivalent |
| K934390 | OSCILLATING BONE SAW BLADE, 6200 SERIES | Jan 26, 1994 | Substantially Equivalent |