FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NITROGLYCERINE PUMP SET
K Number: K871084
·
Decision Jul 16, 1987
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
35
Review Days
120
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Basic Information
- Device Name
- NITROGLYCERINE PUMP SET
- K Number
- K871084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Churchill Corp.
- Date Received
- March 18, 1987
- Decision Date
- July 16, 1987
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Churchill Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880025 | CHURCHILL 0.22 MICRON LIQUID FILTER SETS | Apr 14, 1988 | Substantially Equivalent |
| K880026 | CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS | Apr 14, 1988 | Substantially Equivalent |
| K880051 | ENTERAL BAG/SET | Apr 14, 1988 | Substantially Equivalent |
| K880027 | CHURCHILL 1.2 MICRON LIQUID FILTER SET | Apr 13, 1988 | Substantially Equivalent |
| K872585 | CHURCHILL-CATH | Oct 15, 1987 | Substantially Equivalent |
| K870395 | CHURCHILL PARENTERAL NUTRITION BAG - EVA | Oct 15, 1987 | Substantially Equivalent |
| K872124 | CHURCHILL ALBUMIN IV ADMINISTRATION SET | Oct 13, 1987 | Substantially Equivalent |
| K872123 | CHURCHILL TPN ADMINISTRATION SET | Oct 9, 1987 | Substantially Equivalent |
| K872043 | CHURCHILL INTER-CARDIAC SUCKER | Sep 30, 1987 | Substantially Equivalent |
| K871085 | EXTENSION TUBE PUMP SET | Jun 15, 1987 | Substantially Equivalent |