510(k) K955026
K955026 is an FDA 510(k) premarket notification submitted by Datex Medical Instrumentation, Inc. for the device "AS/3 NMT MODULE". The FDA issued a decision of Substantially Equivalent on April 28, 1997. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Datex Medical Instrumentation, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1997
- Date Received
- November 2, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type