FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG MONITOR MODEL RM102
K Number: K851496
·
Decision Jul 24, 1985
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
77
Applicant Total
69
Review Days
100
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Basic Information
- Device Name
- ECG MONITOR MODEL RM102
- K Number
- K851496
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Honeywell, Inc.
- Date Received
- April 15, 1985
- Decision Date
- July 24, 1985
- Product Code
- DXJ
- 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 |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | FDA class 2 | Cardiovascular |
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