Clearance Summary
0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER received FDA 510(k) clearance under submission number K961208, sponsored by Ptw-New York Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-06-17.
- Submission: K961208
- Applicant / Sponsor: Ptw-New York Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1996-06-17
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.