510(k) K933232
K933232 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Boehringer Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1994
- Date Received
- July 6, 1993
- 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