Insight Electronic Alignment Indicator
FDA 510(k) K940812 · Andronic Devices, Ltd.
510(k) numberK940812
Submission
- Device name
- Insight Electronic Alignment Indicator
- Applicant
- Andronic Devices, Ltd.
Richmond, B.C. Canada V6v 2j2, CA - Received
- February 22, 1994
- Decision date
- November 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQX – Goniometer, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1500
- Specialty
- Orthopedic
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| K943898 | Saunders Electronic InclinometerKQX · Traditional | The Saunders Group | 11/28/1994SE |
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More from Isotechnologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934928 | Insite Filter & Tubing SetHIF · Traditional | 05/26/1994SE |
| K934926 | Insite Model 20 & Model 15 InsufflatorsHIF · Traditional | 05/26/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | 04/15/1994SE |
| K934124 | Autoquot Automated Aliquotting SystemJQW · Traditional | 04/13/1994SE |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | 03/31/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | 10/19/1992SE |
| K911521 | Arthrobot(Tm) 96 (240 CM) Drape with 1 StrapKKX · Traditional | 08/02/1991SE |
| K911520 | Arthrobot(Tm) 75 (190 CM) General Purpose DrapeKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Insight Electronic Alignment Indicator cleared by the FDA?
Insight Electronic Alignment Indicator (K940812) received a 510(k) decision of Substantially Equivalent on November 21, 1994, 272 days after the submission was received.
What is the product code of K940812?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.