PEDIATRIC INSTATRAK SYSTEM— 510(k) K981998
Substantially EquivalentVisualization Technology, Inc.
FDA 510(k) clearance K981998 for PEDIATRIC INSTATRAK SYSTEM, Substantially Equivalent on 1998-08-21. Applicant: Visualization Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Visualization Technology, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code LLZ
view allMore clearances from Visualization Technology, Inc.
view all- K003510 — INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
- K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
- K990919 — STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
- K983529 — INSTATRAK 3000
- K982994 — SKULL BASE INSTATRAK SYSTEM
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K981998
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 K981998.
Data sourced from openFDA. This site is unofficial and independent of the FDA.