510(k) K926140
K926140 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "VACUUM POWER BODY FLUID SUCTION APPARATUS". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1993
- Date Received
- December 7, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Regulator, Vacuum
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type