FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
K Number: K960449
·
Decision May 30, 1996
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
10
Review Days
121
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Basic Information
- Device Name
- PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
- K Number
- K960449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosensor Corp.
- Date Received
- January 30, 1996
- Decision Date
- May 30, 1996
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Biosensor Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K990956 | BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 | Jun 14, 1999 | Substantially Equivalent |
| K974546 | BIOSENSOR HOLTER MONITOR SYSTEM | Mar 4, 1998 | Substantially Equivalent |
| K974192 | BIOSENSOR HOLTER MONITOR SYSTEM | Mar 4, 1998 | Substantially Equivalent |
| K950944 | AMBULATORY (HOLTER) RECORDING SYSTEM | Jun 18, 1996 | Substantially Equivalent |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | Apr 12, 1996 | Substantially Equivalent |
| K950723 | AMBULATORY (HOLTER) RECORDING SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K922027 | AMBULATORY (HOLTER) RECORDING, MODIFICATION | Feb 17, 1993 | Substantially Equivalent |
| K895266 | AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED | Jan 26, 1990 | Substantially Equivalent |
| K831676 | BIOSENSOR ASC SYSTEM | Dec 1, 1983 | Substantially Equivalent |