FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAMBRIDGE VS-550 ELECTROCARDIOGRAPH
K Number: K800566
·
Decision Apr 8, 1980
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
13
Review Days
26
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Basic Information
- Device Name
- CAMBRIDGE VS-550 ELECTROCARDIOGRAPH
- K Number
- K800566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Instruments, Inc.
- Date Received
- March 13, 1980
- Decision Date
- April 8, 1980
- 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 Cambridge Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811121 | CENTRAL STATION MONITORING SYSTEMS | Jun 30, 1981 | Substantially Equivalent |
| K811062 | CAMPBRIDGE COMPUTRACE | May 29, 1981 | Substantially Equivalent |
| K803229 | 4-CHANNEL ECG TELEMETRY MON. SYST. #3045 | Jan 13, 1981 | Substantially Equivalent |
| K801224 | CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM | Jun 26, 1980 | Substantially Equivalent |
| K792661 | TREADMILL MODEL 3060 | Feb 19, 1980 | Substantially Equivalent |
| K791201 | SCINTISTRESS SYSTEM | Sep 17, 1979 | Substantially Equivalent |
| K790509 | CARDIOCASSETTE II, AMBULATORY ECG SYSTEM | Mar 23, 1979 | Substantially Equivalent |
| K761318 | 3038 OPTION B-COMPUT. TRANS. TERMINAL | Jan 6, 1977 | Substantially Equivalent |
| K761198 | MODEL 3044 3-CHANNEL STRESS TEST SYSTEM | Dec 9, 1976 | Substantially Equivalent |
| K760926 | ELECTROCARDIOGRAPH (MODEL VS-4B) | Nov 9, 1976 | Substantially Equivalent |