Neurotronics Polysomnography System 101
FDA 510(k) K971803 · Neurotronics, Inc.
510(k) numberK971803
Submission
- Device name
- Neurotronics Polysomnography System 101
- Applicant
- Neurotronics, Inc.
Waldo, FL, US - Received
- May 12, 1997
- Decision date
- November 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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Questions and answers
When was Neurotronics Polysomnography System 101 cleared by the FDA?
Neurotronics Polysomnography System 101 (K971803) received a 510(k) decision of Substantially Equivalent on November 12, 1997, 184 days after the submission was received.
What is the product code of K971803?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.