The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Portable Suction Unit.
| Device ID | K932031 |
| 510k Number | K932031 |
| Device Name: | AMBU PORTABLE SUCTION UNIT |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Contact | David Lee |
| Correspondent | David Lee AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1995-05-05 |