MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES— 510(k) K012837
Substantially EquivalentDatex-Ohmeda
FDA 510(k) clearance K012837 for MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES, Substantially Equivalent on 2001-09-14. Applicant: Datex-Ohmeda. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda
- Product code
- Code MLD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Needham, MA, US
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More clearances from Datex-Ohmeda
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