PMH 1000 HEATED HUMIDIFIER— 510(k) K013856
Substantially EquivalentPegasus Research Corp.
FDA 510(k) clearance K013856 for PMH 1000 HEATED HUMIDIFIER, Substantially Equivalent on 2003-02-21. Applicant: Pegasus Research Corp.. Device class: 2.
Clearance details
- Applicant
- Pegasus Research Corp.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code BTT
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- K983783 — HEATED HUMIDIFIER
- K962534 — THERA-MIST NEBULIZER MODEL-P3000
- K946057 — AQUALARM MOISTURE SENSOR MODEL P85000
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.