Clearance Summary
TELEMETRY POWER PACK MODEL 2 received FDA 510(k) clearance under submission number K891927, sponsored by Lucas & Rhea Mfg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1990-04-26.
- Submission: K891927
- Applicant / Sponsor: Lucas & Rhea Mfg.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1990-04-26
Classification & Regulation
This clearance is catalogued under FDA product code FCP and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.