Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator

About This 510(k) Submission

K152931 is an FDA 510(k) clearance for the Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on August 29, 2016, 329 days after receiving the submission on October 5, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.