FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDABAROGRAPH
K Number: K861260
·
Decision May 2, 1986
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
10
Applicant Total
1
Review Days
29
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Basic Information
- Device Name
- PEDABAROGRAPH
- K Number
- K861260
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1600
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Biokinetics, Inc.
- Date Received
- April 3, 1986
- Decision Date
- May 2, 1986
- Product Code
- JFC
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | FDA class 1 | Physical Medicine |
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