Clearance Summary
PERALISTIC PUMP MODEL 2000 received FDA 510(k) clearance under submission number K780789, sponsored by Innovative Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1978-06-13.
- Submission: K780789
- Applicant / Sponsor: Innovative Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2750
- Decision date: 1978-06-13
Classification & Regulation
This clearance is catalogued under FDA product code JQW and 21 CFR 862.2750, within the Clinical Chemistry review panel as a Class I device.