The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Spur Infant/child W/o Pressure-limiting Valve.
| Device ID | K923762 |
| 510k Number | K923762 |
| Device Name: | SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1993-02-05 |