Sapphire 4ME Emg/Ep System
FDA 510(k) K912775 · Medelec Intl. Corp.
510(k) numberK912775
Submission
- Device name
- Sapphire 4ME Emg/Ep System
- Applicant
- Medelec Intl. Corp.
England, GB - Received
- June 24, 1991
- Decision date
- November 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K865106 | Prophylactic (Condom) Mr. JohnnyHIS · Traditional | 05/20/1987SE |
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Questions and answers
When was Sapphire 4ME Emg/Ep System cleared by the FDA?
Sapphire 4ME Emg/Ep System (K912775) received a 510(k) decision of Substantially Equivalent on November 8, 1991, 137 days after the submission was received.
What is the product code of K912775?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.