CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL— 510(k) K881625
Substantially EquivalentRespiratory Care, Inc.
FDA 510(k) clearance K881625 for CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL, Substantially Equivalent on 1988-06-21. Applicant: Respiratory Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Respiratory Care, Inc.
- Product code
- Code BZE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5270
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington Heights, IL, US
Recent devices under product code BZE
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- K234032 — Hudson RCI Dri-Tech Breathing Circuits +6 more
More clearances from Respiratory Care, Inc.
view allAdverse events under product code BZE
product code BZE- Death
- 4
- Malfunction
- 910
- Other
- 1
- Total
- 915
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.