K853095 is an FDA 510(k) clearance for the BOEHRINGER LABORATORIES SUCTION INTERMITTOR. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on August 23, 1985, 31 days after receiving the submission on July 23, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K853095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1985 |
| Decision Date | August 23, 1985 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |