The following data is part of a premarket notification filed by Laerdal California, Inc. with the FDA for E-vac(tm).
| Device ID | K862875 |
| 510k Number | K862875 |
| Device Name: | E-VAC(TM) |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | LAERDAL CALIFORNIA, INC. 1901 OBISPO AVE. Long Beach, CA 90804 |
| Contact | Geoffrey C Garth |
| Correspondent | Geoffrey C Garth 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 | 1986-07-30 |
| Decision Date | 1986-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045430014930 | K862875 | 000 |
| 07045432105988 | K862875 | 000 |
| 07045432106374 | K862875 | 000 |