DRUG NEBULIZERS— 510(k) K911422
Substantially EquivalentIntersurgical, Inc.
FDA 510(k) clearance K911422 for DRUG NEBULIZERS, Substantially Equivalent on 1991-10-23. Applicant: Intersurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intersurgical, Inc.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cazenovia, NY, US
Recent devices under product code CAF
view allMore clearances from Intersurgical, Inc.
view all- K122077 — MANOMETER
- K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
- K121026 — FLO-GUARD BREATHING FILTER
- K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
- K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
Adverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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.