Mark 20 and Mark 25 Hand Engine Controller
FDA 510(k) K964860 · Bell Intl., Inc.
510(k) numberK964860
Submission
- Device name
- Mark 20 and Mark 25 Hand Engine Controller
- Applicant
- Bell Intl., Inc.
Burlingame, CA, US - Received
- December 4, 1996
- Decision date
- March 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
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More from Guilin Woodpecker Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K964863 | Model 45E Handengine & Controller, Model 45EH Handengine & Controller, Model RX-100…EBW · Traditional | 02/28/1997SE |
Questions and answers
When was Mark 20 and Mark 25 Hand Engine Controller cleared by the FDA?
Mark 20 and Mark 25 Hand Engine Controller (K964860) received a 510(k) decision of Substantially Equivalent on March 3, 1997, 89 days after the submission was received.
What is the product code of K964860?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.