Clearance Summary
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) received FDA 510(k) clearance under submission number K881967, sponsored by Challenge Mfg., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1988-06-13.
- Submission: K881967
- Applicant / Sponsor: Challenge Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 1988-06-13
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.