MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA— 510(k) K845021
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K845021 for MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA, Substantially Equivalent on 1985-05-20. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
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Adverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
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.