The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Matic Automatic Resuscitator.
| Device ID | K904920 |
| 510k Number | K904920 |
| Device Name: | AMBU MATIC AUTOMATIC RESUSCITATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | AMBU, INC. 7476 NEW RIDGE RD-STE D Hanover, MD 21076 |
| Contact | David Lee |
| Correspondent | David Lee AMBU, INC. 7476 NEW RIDGE RD-STE D Hanover, MD 21076 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-31 |
| Decision Date | 1991-05-28 |