The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Spur Ii Adult Resuscitator, Ambu Spur Ii Pediatric Resuscitator, Ambu Spur Ii Infant Resuscitator.
| Device ID | K152931 |
| 510k Number | K152931 |
| Device Name: | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | AMBU A/S BALTORPBAKKEN 13 Ballerup, DK Dk-2750 |
| Contact | Line Kagenow Svenstrup |
| Correspondent | Sanjay Parikh AMBU INC. 6230 OLD DOBBIN LANE, SUITE 250 Columbia, MD 21045 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-05 |
| Decision Date | 2016-08-29 |
| Summary: | summary |