FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNICORDER, MODEL 464
K Number: K990027
·
Decision Feb 9, 1999
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
54
Review Days
35
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Basic Information
- Device Name
- OMNICORDER, MODEL 464
- K Number
- K990027
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Del Mar Avionics
- Date Received
- January 5, 1999
- Decision Date
- February 9, 1999
- 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 Del Mar Avionics
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K884887 | MODEL 499 SSR ANALYSIS SYSTEM | Feb 6, 1989 | Substantially Equivalent |