Clearance Summary
PENTAX ST-1A received FDA 510(k) clearance under submission number K780738, sponsored by Hal-Hen Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1978-07-17.
- Submission: K780738
- Applicant / Sponsor: Hal-Hen Co., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 1978-07-17
Classification & Regulation
This clearance is catalogued under FDA product code DQD and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.