DISPOSABLE DOME STOCK #D-300— 510(k) K884919
Substantially EquivalentAdvanced Medical, Inc.
FDA 510(k) clearance K884919 for DISPOSABLE DOME STOCK #D-300, Substantially Equivalent on 1989-01-05. Applicant: Advanced Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Medical, Inc.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huntington Beach, CA, US
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- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Advanced Medical, Inc.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.