Submission Details
| 510(k) Number | K241882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 28, 2024 |
| Decision Date | August 27, 2025 |
| Days to Decision | 425 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
Fetal & Maternal Monitor (F15A, F15A Air)
Aug 2025
Decision
425d
Days
Class 2
Risk
About This 510(k) Submission
K241882 is an FDA 510(k) clearance for the Fetal & Maternal Monitor (F15A, F15A Air), a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 27, 2025, 425 days after receiving the submission on June 28, 2024. 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
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