HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE— 510(k) K942842
Substantially EquivalentHewlett-Packard GmbH
FDA 510(k) clearance K942842 for HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE, Substantially Equivalent on 1995-02-16. Applicant: Hewlett-Packard GmbH. Device class: 2.
Clearance details
- Applicant
- Hewlett-Packard GmbH
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 71004 Boblingen, DE
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More clearances from Hewlett-Packard GmbH
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- K992595 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
- K992674 — HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
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Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.