FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IPG-II MODULE
K Number: K903700
·
Decision Jan 16, 1991
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
12
Review Days
154
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Basic Information
- Device Name
- IPG-II MODULE
- K Number
- K903700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Sciences Manufacturing, Inc.
- Date Received
- August 15, 1990
- Decision Date
- January 16, 1991
- Product Code
- DSB
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 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 |
| 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 |
| K811560 | AUTOMATED PHYSIOLOGIC PROFILE MONITOR | Jun 18, 1981 | Substantially Equivalent |