Clearance Summary
H 5100, H 5200, H 5300 received FDA 510(k) clearance under submission number K945507, sponsored by Rudolf Riester GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-12-09.
- Submission: K945507
- Applicant / Sponsor: Rudolf Riester GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6320
- Decision date: 1994-12-09
Classification & Regulation
This clearance is catalogued under FDA product code KZF and 21 CFR 880.6320, within the General Hospital review panel as a Class I device.