SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)— 510(k) K961476
Substantially EquivalentSalter Labs
FDA 510(k) clearance K961476 for SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984), Substantially Equivalent on 1996-07-16. Applicant: Salter Labs. Device class: 2.
Clearance details
- Applicant
- Salter Labs
- 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
- Arvin, CA, US
Recent devices under product code CAF
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view all- K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- K161719 — Salter Labs Bubble Humidifier
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
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 →
Recalls naming K961476
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 K961476.
Data sourced from openFDA. This site is unofficial and independent of the FDA.