Clearance Summary
VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF received FDA 510(k) clearance under submission number K874367, sponsored by Spembly Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-01-04.
- Submission: K874367
- Applicant / Sponsor: Spembly Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 1988-01-04
Classification & Regulation
This clearance is catalogued under FDA product code HQO and 21 CFR 886.4115, within the Ophthalmic review panel as a Class II device.