FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED SEISMOCARDIOGRAPH
K Number: K900130
·
Decision Mar 28, 1990
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
3
Review Days
82
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
- MODIFIED SEISMOCARDIOGRAPH
- K Number
- K900130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Seismed Instruments, Inc.
- Date Received
- January 5, 1990
- Decision Date
- March 28, 1990
- 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