K850200 is an FDA 510(k) clearance for the SUCTION REGULATOR 7700 SERIES. 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 4, 1985, 45 days after receiving the submission on January 18, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K850200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1985 |
| Decision Date | March 04, 1985 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDP — Regulator, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |