NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES— 510(k) K971436
Substantially Equivalent - Subject to Tracking Reg.Nihon Kohden America, Inc.
FDA 510(k) clearance K971436 for NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES, Substantially Equivalent - Subject to Tracking Reg. on 1997-10-21. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, Inc.
- Product code
- Code LDD
- Device class
- Class 2
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Adverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
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.