Clearance Summary
CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 received FDA 510(k) clearance under submission number K924234, sponsored by Fisher & Paykel Electronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1993-05-27.
- Submission: K924234
- Applicant / Sponsor: Fisher & Paykel Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 1993-05-27
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.