FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
INSIGHT ELECTRONIC ALIGNMENT INDICATOR
K Number: K940812
·
Decision Nov 21, 1994
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
16
Review Days
272
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Basic Information
- Device Name
- INSIGHT ELECTRONIC ALIGNMENT INDICATOR
- K Number
- K940812
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andronic Devices, Ltd.
- Date Received
- February 22, 1994
- Decision Date
- November 21, 1994
- 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 Andronic Devices, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K934926 | INSITE MODEL 20 & MODEL 15 INSUFFLATORS | May 26, 1994 | Substantially Equivalent |
| K934928 | INSITE FILTER & TUBING SET | May 26, 1994 | Substantially Equivalent |
| K935381 | KAPS POSITIONING ARM | Apr 15, 1994 | Substantially Equivalent |
| K934124 | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM | Apr 13, 1994 | Substantially Equivalent |
| K936308 | ENDEX ENDOSCOPIC POSITIONING SYSTEM | Mar 31, 1994 | Substantially Equivalent |
| K932253 | ARTHROBOT BI-FOLD DRAPE | Feb 3, 1994 | Substantially Equivalent |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Oct 19, 1992 | Substantially Equivalent |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Oct 19, 1992 | Substantially Equivalent |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Aug 2, 1991 | Substantially Equivalent |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Aug 2, 1991 | Substantially Equivalent |