FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANDHELD DYNAMOMETER, MODEL #160 AND #111
K Number: K861396
·
Decision May 2, 1986
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
11
Applicant Total
2
Review Days
17
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Basic Information
- Device Name
- HANDHELD DYNAMOMETER, MODEL #160 AND #111
- K Number
- K861396
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1250
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Spark Instruments & Academics, Inc.
- Date Received
- April 15, 1986
- Decision Date
- May 2, 1986
- Product Code
- HRW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HRW | Dynamometer, Nonpowered | FDA class 1 | Orthopedic |
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Other Clearances by Spark Instruments & Academics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884165 | MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS | Oct 26, 1988 | Substantially Equivalent |