510(k) K971803
K971803 is an FDA 510(k) premarket notification submitted by Neurotronics, Inc. for the device "NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101". The FDA issued a decision of Substantially Equivalent on November 12, 1997. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Neurotronics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1997
- Date Received
- May 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type