K933232 is an FDA 510(k) clearance for the BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED. This device is classified as a Regulator, Vacuum (Class II - Special Controls, product code KDP).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 28, 1994, 265 days after receiving the submission on July 6, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K933232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1993 |
| Decision Date | March 28, 1994 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KDP — Regulator, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |