Ambu A/S
Glen Burnie, MD, US
Ambu A/S appears in FDA device records in Glen Burnie, MD. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Ambu A/S between 2005 and 2013. The busiest year on record is 2005, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 2 |
| 2010 | 3 |
| 2011 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130845 | AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW | EOQ | Substantially Equivalent | |
| K110962 | AMBU ASCOPE 2 | BTR | Substantially Equivalent | |
| K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | BTM | Substantially Equivalent | |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | DRX | Substantially Equivalent | |
| K093186 | AMBU ASCOPE AND MONITOR | BTR | Substantially Equivalent | |
| K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE | IKT | Substantially Equivalent | |
| K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | IKT | Substantially Equivalent | |
| K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | GXZ | Substantially Equivalent | |
| K053550 | AMBU BLUE SENSOR NEO AND NEO X | DRX | Substantially Equivalent | |
| K052944 | AMBU WHITE SENSOR CFM, CFL | DRX | Substantially Equivalent | |
| K053140 | AMBU MARK IV RESUSCITATOR | BTM | Substantially Equivalent | |
| K053142 | AMBU MARK IV BABY RESUSCITATOR | BTM | Substantially Equivalent | |
| K051529 | AMBU NEUROLINE GROUND | GXY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain