FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)
K Number: K862714
·
Decision Nov 17, 1986
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
4
Review Days
124
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Basic Information
- Device Name
- BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)
- K Number
- K862714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Electro-Diagnostic Instruments
- Date Received
- July 16, 1986
- Decision Date
- November 17, 1986
- 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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