HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
FDA 510(k) clearance K102263 · decided 2011-05-05
Clearance details
- K-number
- K102263
- Device name
- HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
- Applicant
- Mckesson Information Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-08-10
- Decision date
- 2011-05-05
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.