FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PM
K Number: K925980
·
Decision Mar 24, 1993
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
2
Review Days
119
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Basic Information
- Device Name
- PM
- K Number
- K925980
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pathfinder Intl. Corp.
- Date Received
- November 25, 1992
- Decision Date
- March 24, 1993
- Product Code
- KNN
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
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Other Clearances by Pathfinder Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843698 | CLOSED URINARY DRAINAGE UNIT | Dec 17, 1984 | Substantially Equivalent |