Submission Details
| 510(k) Number | K220732 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2022 |
| Decision Date | June 23, 2022 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
Mural Perinatal Surveillance
Jun 2022
Decision
101d
Days
Class 2
Risk
About This 510(k) Submission
K220732 is an FDA 510(k) clearance for the Mural Perinatal Surveillance, a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on June 23, 2022, 101 days after receiving the submission on March 14, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.
Device Classification
| Product Code | HGM — System, Monitoring, Perinatal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2740 |
Manufacturer
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI · US
Brandon O'Shea
31 submissions
31 cleared
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