FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENTINEL RECORDER, MODELS 471/472
K Number: K971696
·
Decision Dec 30, 1997
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
54
Review Days
236
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Basic Information
- Device Name
- SENTINEL RECORDER, MODELS 471/472
- K Number
- K971696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Del Mar Avionics
- Date Received
- May 8, 1997
- Decision Date
- December 30, 1997
- Product Code
- DXH
- 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Del Mar Avionics
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|---|---|---|---|
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| 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 |