FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
K Number: K853652
·
Decision Jan 16, 1986
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
3
Review Days
135
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Basic Information
- Device Name
- BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
- K Number
- K853652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Fisher Imaging Corp.
- Date Received
- September 3, 1985
- Decision Date
- January 16, 1986
- Product Code
- DRR
- 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 |
|---|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | FDA class 2 | Cardiovascular |
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