Clearance Summary
TELETOM received FDA 510(k) clearance under submission number K940405, sponsored by Berchtold Holding GmbH. 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 1994-04-14.
- Submission: K940405
- Applicant / Sponsor: Berchtold Holding GmbH
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 1994-04-14
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.