TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)— 510(k) K893609
Substantially EquivalentLeonides Y. Teves, M.D., P.A.
FDA 510(k) clearance K893609 for TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR), Substantially Equivalent on 1989-10-30. Applicant: Leonides Y. Teves, M.D., P.A.. Device class: 2.
Clearance details
- Applicant
- Leonides Y. Teves, M.D., P.A.
- Product code
- Code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bradenton, FL, US
Recent devices under product code BTR
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- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K243579 — AeroJet Ventilation Catheter
Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
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.