FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
EP AMP, MODEL #901
K Number: K925346
·
Decision Apr 30, 1993
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
3
Review Days
190
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
- EP AMP, MODEL #901
- K Number
- K925346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quinton Electrophysiology Corp.
- Date Received
- October 22, 1992
- Decision Date
- April 30, 1993
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRR), ordered by most recent decision date.
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
FDA 510(k)
FDA Class 2
·Cardiovascular
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
FDA 510(k)
FDA Class 2
·Cardiovascular
HORIZON 9000/HIS OPTION AMPLIFIER
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOLAB AMPLIFIER MODULE (CAM)
FDA 510(k)
FDA Class 2
·Cardiovascular
ASC-952 PHYSIOLOGICAL AMPLIFIER
FDA 510(k)
FDA Class 2
·Cardiovascular