MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.— 510(k) K895244
Substantially EquivalentNational Medical Care, Medical Products Div., Inc.
FDA 510(k) clearance K895244 for MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD., Substantially Equivalent on 1990-02-12. Applicant: National Medical Care, Medical Products Div., Inc.. Device class: 2.
Clearance details
- Applicant
- National Medical Care, Medical Products Div., Inc.
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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More clearances from National Medical Care, Medical Products Div., Inc.
view allAdverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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.