Clearance Summary
NPAC EAR THERMOMETER MODEL TD 402 received FDA 510(k) clearance under submission number K011704, sponsored by Norm Pacific Automation Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-06-27.
- Submission: K011704
- Applicant / Sponsor: Norm Pacific Automation Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-06-27
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.