MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A— 510(k) K071058
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K071058 for MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A, Substantially Equivalent on 2007-06-29. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Foothill, CA, US
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Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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 →
Recalls naming K071058
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071058.
Data sourced from openFDA. This site is unofficial and independent of the FDA.