The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Spur (single Patient Use Resuscitator).
| Device ID | K883434 |
| 510k Number | K883434 |
| Device Name: | AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | AMBU, INC. 7476 NEW RIDGE RD-STE D Hanover, MD 21076 |
| Contact | Frank Homa |
| Correspondent | Frank Homa 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 | 1988-08-15 |
| Decision Date | 1988-09-14 |