K950698 is an FDA 510(k) clearance for the LSU 2000 PORTABLE SUCTION UNIT, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Laerdal Medical Corp. (Armonk, US). The FDA issued a Cleared decision on May 9, 1995, 88 days after receiving the submission on February 10, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K950698 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 10, 1995 |
| Decision Date | May 09, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4780 |