FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOGUARD STRESS TEST MONITOR 4002
K Number: K850043
·
Decision Feb 8, 1985
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
54
Review Days
32
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Basic Information
- Device Name
- CARDIOGUARD STRESS TEST MONITOR 4002
- K Number
- K850043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Del Mar Avionics
- Date Received
- January 7, 1985
- Decision Date
- February 8, 1985
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Del Mar Avionics
| K Number | Device Name | ||
|---|---|---|---|
| K990027 | OMNICORDER, MODEL 464 | Feb 9, 1999 | Substantially Equivalent |
| K971696 | SENTINEL RECORDER, MODELS 471/472 | Dec 30, 1997 | Substantially Equivalent |
| K963174 | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) | Mar 13, 1997 | Substantially Equivalent |
| K950020 | HOLTER PACERCORDER(R) | Aug 17, 1995 | Substantially Equivalent |
| K942653 | HOLTER SSR DIGICORDER(TM) | May 10, 1995 | Substantially Equivalent |
| K922221 | SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM | Apr 21, 1993 | Substantially Equivalent |
| K896862 | MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM | Apr 18, 1990 | Substantially Equivalent |
| K895793 | MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION | Feb 13, 1990 | Substantially Equivalent |
| K894543 | MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER | Feb 8, 1990 | Substantially Equivalent |
| K891148 | MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM | May 11, 1989 | Substantially Equivalent |