Clearance Summary
IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE received FDA 510(k) clearance under submission number K941850, sponsored by Tnt Moborg Intl. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-07-14.
- Submission: K941850
- Applicant / Sponsor: Tnt Moborg Intl. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1994-07-14
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.