The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Spur Ii Infant And Pediatric Single Patient Use Resuscitators.
| Device ID | K042843 |
| 510k Number | K042843 |
| Device Name: | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD Linthicum, MD 21090 -1356 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD 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 | 2004-10-14 |
| Decision Date | 2004-11-12 |