K884103 is an FDA 510(k) clearance for the REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES. 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 March 3, 1989, 155 days after receiving the submission on September 29, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K884103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1988 |
| Decision Date | March 03, 1989 |
| Days to Decision | 155 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 |