FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVENT MASTER
K Number: K812920
·
Decision Dec 2, 1981
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
8
Review Days
44
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Basic Information
- Device Name
- EVENT MASTER
- K Number
- K812920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Instruments For Cardiac Research
- Date Received
- October 19, 1981
- Decision Date
- December 2, 1981
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 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 |
| K801903 | SERIES 4000 STRESS & EXERCISE SYSTEM | Mar 11, 1981 | Substantially Equivalent |
| K771374 | SCANNER TREND SYSTEM | Aug 4, 1977 | Substantially Equivalent |
| K770705 | CARDIAC ACQUISITION SYSTEM, ICR 2001 | Jun 2, 1977 | Substantially Equivalent |