FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
K Number: K892323
·
Decision Oct 30, 1989
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
3
Review Days
207
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Basic Information
- Device Name
- SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
- K Number
- K892323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Seismed Instruments, Inc.
- Date Received
- April 6, 1989
- Decision Date
- October 30, 1989
- 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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