The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Lsu 2000 Portable Suction Unit.
| Device ID | K950698 |
| 510k Number | K950698 |
| Device Name: | LSU 2000 PORTABLE SUCTION UNIT |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | LAERDAL MEDICAL CORP. ONE LABRIOLA COURT Armonk, NY 10504 -0190 |
| Contact | Ronald L Weyhrauch |
| Correspondent | Ronald L Weyhrauch LAERDAL MEDICAL CORP. ONE LABRIOLA COURT Armonk, NY 10504 -0190 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-10 |
| Decision Date | 1995-05-09 |