MIROCAM CAPSULE ENDOSCOPE SYSTEM— 510(k) K111450
Substantially EquivalentIntromedic Co., Ltd.
FDA 510(k) clearance K111450 for MIROCAM CAPSULE ENDOSCOPE SYSTEM, Substantially Equivalent on 2012-05-18. Applicant: Intromedic Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Intromedic Co., Ltd.
- Product code
- Code NEZ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
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More clearances from Intromedic Co., Ltd.
view allAdverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
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.