CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60— 510(k) K001213
Substantially EquivalentHudson Respiratory Care, Inc.
FDA 510(k) clearance K001213 for CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60, Substantially Equivalent on 2000-11-03. Applicant: Hudson Respiratory Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Hudson Respiratory Care, Inc.
- 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
- Temecula, CA, US
Recent devices under product code BTT
view allMore clearances from Hudson Respiratory Care, Inc.
view all- K031383 — MODEL 780
- K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
- K011134 — OXYGEN SUPPLY TUBING, MODEL 1115
- K010402 — SMOOTH-FLO CIRCUIT
- K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
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.