Datex-Ohmeda S/5 PSM Module, (Consisting of E-Psm and E-Psmp Modules) and Accessories
FDA 510(k) K043551 · Datex-Ohmeda
510(k) numberK043551
Submission
- Device name
- Datex-Ohmeda S/5 PSM Module, (Consisting of E-Psm and E-Psmp Modules) and Accessories
- Applicant
- Datex-Ohmeda
Needham, MA, US - Received
- December 23, 2004
- Decision date
- February 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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Questions and answers
When was Datex-Ohmeda S/5 PSM Module, (Consisting of E-Psm and E-Psmp Modules) and Accessories cleared by the FDA?
Datex-Ohmeda S/5 PSM Module, (Consisting of E-Psm and E-Psmp Modules) and Accessories (K043551) received a 510(k) decision of Substantially Equivalent on February 18, 2005, 57 days after the submission was received.
What is the product code of K043551?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.