FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC ACQUISITION SYSTEM, ICR 2001
K Number: K770705
·
Decision Jun 2, 1977
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
8
Review Days
45
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Basic Information
- Device Name
- CARDIAC ACQUISITION SYSTEM, ICR 2001
- K Number
- K770705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Instruments For Cardiac Research
- Date Received
- April 18, 1977
- Decision Date
- June 2, 1977
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Instruments For Cardiac Research
| K Number | Device Name | ||
|---|---|---|---|
| K834397 | HOLTER CARDIOGRAPHY SYS 6201 | Apr 17, 1984 | Substantially Equivalent |
| K821173 | EVENTMASTER 3 HOLTER EVENT SCANNER | May 18, 1982 | Substantially Equivalent |
| K820856 | EVENTMASTER 2 | Apr 29, 1982 | Substantially Equivalent |
| K820011 | CARDIOSTRESS | Jan 22, 1982 | Substantially Equivalent |
| K812920 | EVENT MASTER | Dec 2, 1981 | Substantially Equivalent |
| K801903 | SERIES 4000 STRESS & EXERCISE SYSTEM | Mar 11, 1981 | Substantially Equivalent |
| K771374 | SCANNER TREND SYSTEM | Aug 4, 1977 | Substantially Equivalent |