Clearance Summary
NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 received FDA 510(k) clearance under submission number K934368, sponsored by Nk Biotechnical Engineering Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1994-08-11.
- Submission: K934368
- Applicant / Sponsor: Nk Biotechnical Engineering Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 1994-08-11
Classification & Regulation
This clearance is catalogued under FDA product code LLN and 21 CFR 882.1200, within the Neurology review panel as a Class I device.