THERA-MIST NEBULIZER MODEL-P3000— 510(k) K962534
Substantially EquivalentPegasus Research Corp.
FDA 510(k) clearance K962534 for THERA-MIST NEBULIZER MODEL-P3000, Substantially Equivalent on 1997-02-28. Applicant: Pegasus Research Corp.. Device class: 2.
Clearance details
- Applicant
- Pegasus Research Corp.
- 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
- Santa Ana, CA, US
Recent devices under product code CAF
view allMore clearances from Pegasus Research Corp.
view all- K122857 — HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
- K020700 — PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
- K013856 — PMH 1000 HEATED HUMIDIFIER
- K983783 — HEATED HUMIDIFIER
- K946057 — AQUALARM MOISTURE SENSOR MODEL P85000
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.