FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEGATOVE PRESSURE CONVERTOR
K Number: K791164
·
Decision Oct 4, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
5
Review Days
101
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Basic Information
- Device Name
- NEGATOVE PRESSURE CONVERTOR
- K Number
- K791164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medicorp, Inc.
- Date Received
- June 25, 1979
- Decision Date
- October 4, 1979
- Product Code
- FLC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FLC | Station, Dialysis Control, Negative Pressure Type | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medicorp, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860026 | ULTRAMAX III, DIALYZER REPROCESSING DEVICE | Mar 14, 1986 | Substantially Equivalent |
| K844850 | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT | Apr 2, 1985 | Substantially Equivalent |
| K832705 | ULTRAMAX | Jun 25, 1984 | Substantially Equivalent |
| K791396 | MEDI-TRAK PORTABLE TRACTION DEVICE | Aug 16, 1979 | Substantially Equivalent |