DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
FDA 510(k) clearance K043551 · decided 2005-02-18
Clearance details
- K-number
- K043551
- Device name
- DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
- Applicant
- Datex-Ohmeda
- Decision
- Substantially Equivalent
- Date received
- 2004-12-23
- Decision date
- 2005-02-18
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.