RTC 26-C Inline Aerosol Adapter— 510(k) K162753
Substantially EquivalentInstrumentation Industries, Inc.
FDA 510(k) clearance K162753 for RTC 26-C Inline Aerosol Adapter, Substantially Equivalent on 2017-02-28. Applicant: Instrumentation Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Instrumentation Industries, Inc.
- 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
- Bethel Park, PA, US
Recent devices under product code CAF
view allMore clearances from Instrumentation Industries, Inc.
view all- K180510 — NS 120P-TRS Airway Pressure Gauge
- K113644 — PILOT TUBE REPAIR KIT
- K102127 — ENDOTRACHEAL TUBE CHANGERS
- K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
- K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
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.