The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Sir 2 (silicone Resuscitator), Adult.
| Device ID | K910040 |
| 510k Number | K910040 |
| Device Name: | AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT |
| Classification | Ventilator, Emergency, Manual (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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-04 |
| Decision Date | 1991-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813830022896 | K910040 | 000 |
| 00813830022841 | K910040 | 000 |
| 00813830022742 | K910040 | 000 |
| 00813830020984 | K910040 | 000 |
| 00813830022834 | K910040 | 000 |