FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUTRACKER HEART-RATE MONITOR
K Number: K850867
·
Decision May 16, 1985
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
2
Review Days
76
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Basic Information
- Device Name
- ACCUTRACKER HEART-RATE MONITOR
- K Number
- K850867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Eutectic Electronics, Inc.
- Date Received
- March 1, 1985
- Decision Date
- May 16, 1985
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Eutectic Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894968 | ULTRACOMPACT | Nov 8, 1989 | Substantially Equivalent |