FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NK DEXTERITLY BOARD, MODEL BX001
K Number: K914062
·
Decision Dec 9, 1991
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
15
Review Days
90
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Basic Information
- Device Name
- NK DEXTERITLY BOARD, MODEL BX001
- K Number
- K914062
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nk Biotechnical Engineering Co.
- Date Received
- September 10, 1991
- Decision Date
- December 9, 1991
- Product Code
- KQX
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Nk Biotechnical Engineering Co.
| K Number | Device Name | ||
|---|---|---|---|
| K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | Aug 11, 1994 | Substantially Equivalent |
| K923964 | NK GRASP SENSOR, MODEL GA001 | May 12, 1993 | Substantially Equivalent |
| K923965 | NK GRASP SENSOR, MODEL GA002 | May 12, 1993 | Substantially Equivalent |
| K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | Mar 31, 1993 | Substantially Equivalent |
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Jul 14, 1992 | Substantially Equivalent |
| K921268 | NK DYNA-GRIP SENSOR, MODEL DG001 | Jul 14, 1992 | Substantially Equivalent |
| K914057 | NK PINCH SENSOR, MODEL PA001 | Dec 9, 1991 | Substantially Equivalent |
| K914061 | NK RANGE OF MOTION SENSOR, MODEL RM002 | Dec 9, 1991 | Substantially Equivalent |
| K914056 | NK PINCH SENSOR, MODEL PF002 | Dec 9, 1991 | Substantially Equivalent |
| K914059 | NK DEVIATION SENSOR, MODEL DV001 | Dec 9, 1991 | Substantially Equivalent |