K013976 is an FDA 510(k) clearance for the BOEHRINGER MRI SUCTION REGULATORY. 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 January 8, 2002, 36 days after receiving the submission on December 3, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K013976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2001 |
| Decision Date | January 08, 2002 |
| Days to Decision | 36 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 |