FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
K Number: K971570
·
Decision Dec 29, 1997
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
3
Review Days
244
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Basic Information
- Device Name
- EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
- K Number
- K971570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quinton Electrophysiology Corp.
- Date Received
- April 29, 1997
- Decision Date
- December 29, 1997
- 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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