FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARAGON 420, CARDIAC MONITOR
K Number: K861067
·
Decision Jun 5, 1986
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- PARAGON 420, CARDIAC MONITOR
- K Number
- K861067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Life Sensing Instrument Company, Inc.
- Date Received
- March 20, 1986
- Decision Date
- June 5, 1986
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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