510(k) K041223 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
| Applicant | Maquet Critical Care AB, Bridgewater NJ, US |
| Decision | Substantially Equivalent, Jul 29, 2004 |
| Received | May 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2013 | Maquet Cardiovascular Us Sales, Llc Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180).
Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for Terminated |
CBK | None listed |
| Apr 3, 2012 | Maquet Inc. Servo-i ventilator system
Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Terminated |
CBK | None listed |
| Apr 3, 2012 | Maquet Inc. Servo-s ventilator system
Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Terminated |
CBK | None listed |
| Dec 2, 2011 | Maquet Inc. Maquet Servo-i ventilator system
Device Part number 64 87 800
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory ins Terminated |
CBK | None listed |
| Dec 2, 2011 | Maquet Inc. Maquet Servo-S ventilator system
Device Part number 66 40 440
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory ins Terminated |
CBK | None listed |
| Dec 2, 2011 | Maquet Inc. Maquet PC Board PC1772 Spare Part
Device Part number 64 67 620
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory in Terminated |
CBK | None listed |
| Sep 23, 2008 | MAQUET Inc. SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure Terminated |
CBK | None listed |
| Sep 23, 2008 | MAQUET Inc. SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.