MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD— 510(k) K801874
Substantially EquivalentY
FDA 510(k) clearance K801874 for MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD, Substantially Equivalent on 1980-08-27. Applicant: Y. Device class: 2.
Clearance details
- Applicant
- Y
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Y
view all- K955846 — MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
- K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
- K953225 — IVAC BALL VALCE ADMIN. SETS
- K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
- K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.