Emg Accessory for Posturography
FDA 510(k) K901732 · Neurocom International, Inc.
510(k) numberK901732
Submission
- Device name
- Emg Accessory for Posturography
- Applicant
- Neurocom International, Inc.
Clackamas, OR, US - Received
- April 17, 1990
- Decision date
- September 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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Questions and answers
When was Emg Accessory for Posturography cleared by the FDA?
Emg Accessory for Posturography (K901732) received a 510(k) decision of Substantially Equivalent on September 10, 1991, 511 days after the submission was received.
What is the product code of K901732?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.