Clearance Summary
BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD received FDA 510(k) clearance under submission number K983520, sponsored by Sunrise Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1998-11-06.
- Submission: K983520
- Applicant / Sponsor: Sunrise Medical, Inc.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 1998-11-06
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.