VENTLAB ANESTHESIA CIRCUIT AC 6000— 510(k) K896897
Substantially EquivalentVentlab Corp.
FDA 510(k) clearance K896897 for VENTLAB ANESTHESIA CIRCUIT AC 6000, Substantially Equivalent on 1990-01-26. Applicant: Ventlab Corp.. Device class: 1.
Clearance details
- Applicant
- Ventlab Corp.
- Product code
- Product code CAI
- Device class
- Class 1
- Regulation
- 21 CFR 868.5240
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hackensack, NJ, US
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- K090840 — VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
Adverse events under product code CAI
product code CAI- Malfunction
- 869
- Other
- 1
- Total
- 870
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.