PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A— 510(k) K023931
Substantially EquivalentPhilips Medical Systems, Inc.
FDA 510(k) clearance K023931 for PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A, Substantially Equivalent on 2003-02-24. Applicant: Philips Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems, Inc.
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Da Best, NL
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Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.