Clearance Summary
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM received FDA 510(k) clearance under submission number K942227, sponsored by C.L. Mcintosh & Assoc., 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 1996-06-28.
- Submission: K942227
- Applicant / Sponsor: C.L. Mcintosh & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1996-06-28
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.