Clearance Summary
ENVIRONMENTAL CONTROL UNIT MODEL 7000 received FDA 510(k) clearance under submission number K901028, sponsored by Baylor Biomedical Services. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1990-03-13.
- Submission: K901028
- Applicant / Sponsor: Baylor Biomedical Services
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3725
- Decision date: 1990-03-13
Classification & Regulation
This clearance is catalogued under FDA product code IQA and 21 CFR 890.3725, within the Physical Medicine review panel as a Class II device.