FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VDC
K Number: K791756
·
Decision Nov 27, 1979
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
12
Review Days
83
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Basic Information
- Device Name
- VDC
- K Number
- K791756
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Sciences Manufacturing, Inc.
- Date Received
- September 5, 1979
- Decision Date
- November 27, 1979
- Product Code
- DXG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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Other Clearances by Life Sciences Manufacturing, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | Jul 24, 1991 | Substantially Equivalent |
| K903700 | IPG-II MODULE | Jan 16, 1991 | Substantially Equivalent |
| K900365 | PAG MICROPROCESSOR-CONTROLLED MODULE | Jul 18, 1990 | Substantially Equivalent |
| K896500 | CWD/PPG MODULE | Jul 18, 1990 | Substantially Equivalent |
| K895588 | PORTABLE AIR PLETHYSMOGRAPH | Mar 27, 1990 | Substantially Equivalent |
| K896528 | SFA MODULE | Jan 26, 1990 | Substantially Equivalent |
| K884624 | MVL/MODULAB WITH PVR MODULE | Feb 1, 1989 | Substantially Equivalent |
| K873041 | A-V RECORDER | Feb 4, 1988 | Substantially Equivalent |
| K832679 | NON-INVASIVE CLINICAL VASCULAR LAB | Jan 3, 1984 | Substantially Equivalent |
| K822522 | CUTANEOUS PRESSURE PLETHYSMOGRAPH | Sep 28, 1982 | Substantially Equivalent |