The following data is part of a premarket notification filed by Laerdal California, Inc. with the FDA for Statvac Portable Suction Unit.
| Device ID | K941578 |
| 510k Number | K941578 |
| Device Name: | STATVAC PORTABLE SUCTION UNIT |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | LAERDAL CALIFORNIA, INC. 1901 OBISPO AVE. Long Beach, CA 90804 |
| Contact | Jan Harestad |
| Correspondent | Jan Harestad LAERDAL CALIFORNIA, INC. 1901 OBISPO AVE. Long Beach, CA 90804 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-31 |
| Decision Date | 1994-05-18 |