FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
K Number: K914200
·
Decision Nov 7, 1991
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
11
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
- K Number
- K914200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carolina Medical Electronics
- Date Received
- September 19, 1991
- Decision Date
- November 7, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSB), ordered by most recent decision date.
BCM2-Body Composition Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Re:Balans
FDA 510(k)
FDA Class 2
·Cardiovascular
Edema Guard Monitor (EGM) CardioSet-001
FDA 510(k)
FDA Class 2
·Cardiovascular
SOZO Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
Zynex Monitoring System, Model CM-1600
FDA 510(k)
FDA Class 2
·Cardiovascular
Bodyport Cardiac Scale
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Carolina Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent |
| K864624 | PROBE, UPTAKE, NUCLEAR | Aug 10, 1987 | Substantially Equivalent |
| K843891 | DOPSCAN PLUS DS1060 | Jan 9, 1985 | Substantially Equivalent |
| K837329 | SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND | Jun 7, 1983 | Substantially Equivalent |
| K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY | Mar 12, 1982 | Substantially Equivalent |
| K810561 | DOPSCAN MODEL 1050 | Apr 10, 1981 | Substantially Equivalent |
| K801647 | SONACOLOR 6100 | Aug 20, 1980 | Substantially Equivalent |
| K792540 | SONACOLOR 6000 | Jan 17, 1980 | Substantially Equivalent |
| K772015 | PATIENT HEATER SYSTEM, MODEL PH112 | Nov 15, 1977 | Substantially Equivalent |