BETAJECT BD U100— 510(k) K833705
Substantially EquivalentOrange Medical Instruments, Inc.
FDA 510(k) clearance K833705 for BETAJECT BD U100, Substantially Equivalent on 1984-05-09. Applicant: Orange Medical Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Orange Medical Instruments, Inc.
- Product code
- Code FMI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Orange Medical Instruments, Inc.
view allAdverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.