AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS— 510(k) K042843
Substantially EquivalentAmbu, Inc.
FDA 510(k) clearance K042843 for AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS, Substantially Equivalent on 2004-11-12. Applicant: Ambu, Inc.. Device class: 2.
Clearance details
- Applicant
- Ambu, Inc.
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Linthicum, MD, US
Recent devices under product code BTM
view allMore clearances from Ambu, Inc.
view allAdverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K042843
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042843.
Data sourced from openFDA. This site is unofficial and independent of the FDA.