Servo Med Nystagmograph NG-1
510(k) K843004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843004 | Date30 Oct 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWN
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1460
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Servo Med Nystagmograph NG-1 is a nystagmograph, a device used to record and analyze involuntary eye movements. It is classified as a Class II medical device under regulation 882.1460 and is intended for use in neurology.
The device received traditional 510(k) clearance (K843004) from the FDA on October 30, 1984, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Servo Med, Inc. and is supplied as a reusable instrument for clinical electrophysiological testing.
Questions
AI-generated answers, 19 Sep 2026
What is the primary clinical use of the Servo Med Nystagmograph NG-1, and why is it relevant for neurology departments?
The Servo Med Nystagmograph NG-1 is designed to record and analyze involuntary eye movements, known as nystagmus, which can occur due to neurological conditions. This makes it particularly relevant for neurology departments, as nystagmus is often associated with vestibular disorders, cerebellar dysfunction, or other neurological impairments. By capturing these movements, clinicians can better diagnose and monitor conditions like Ménière’s disease, multiple sclerosis, or peripheral vestibular disorders.
Is the Servo Med Nystagmograph NG-1 intended for single-use or reusable applications, and what does this mean for maintenance?
The Servo Med Nystagmograph NG-1 is supplied as a reusable instrument, meaning it is designed for repeated use in clinical electrophysiological testing. This requires adherence to proper cleaning, sterilization, and maintenance protocols to ensure accuracy and safety between patients. Reusability also implies that facilities must account for calibration and upkeep to comply with regulatory standards.
What regulatory pathway was followed for FDA clearance of this device, and what does ‘substantially equivalent’ mean in this context?
The Servo Med Nystagmograph NG-1 received traditional 510(k) clearance (K843004) under the FDA’s premarket notification process. The term ‘substantially equivalent’ (decision_code: SESE) means the device was determined to have the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device—in this case, an earlier nystagmograph. This classification confirms it meets FDA standards for Class II medical devices without requiring additional clinical trials.
How is the device classified under FDA regulations, and which medical specialty is it primarily associated with?
The Servo Med Nystagmograph NG-1 is classified as a Class II medical device under FDA regulation 21 CFR 882.1460, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness. It is primarily associated with neurology, as its intended use aligns with electrophysiological testing for neurological conditions involving eye movement disorders. The advisory committee designation (NE) further confirms its focus on neurological applications.