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FDA 510(k), K030797, S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
FDA 510(k), K030797, S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
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510(K) Number: K030797
Device Name: S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
Manufacturer: RESMED CORP.
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 03/13/2003
Decision Date: 03/10/2004
Regulation Medical Specialty: Anesthesiology
Device Name: S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
Manufacturer: RESMED CORP.
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 03/13/2003
Decision Date: 03/10/2004
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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