FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
K Number: K871748
·
Decision Jun 10, 1987
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE
- K Number
- K871748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- The Buddy Systems, Inc.
- Date Received
- May 5, 1987
- Decision Date
- June 10, 1987
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by The Buddy Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864318 | THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM | Mar 20, 1987 | Substantially Equivalent |