ESOPHAGEAL INTUBATION DETECTOR
FDA 510(k) clearance K930741 · decided 1993-08-07
Clearance details
- K-number
- K930741
- Device name
- ESOPHAGEAL INTUBATION DETECTOR
- Applicant
- Wolfe-Carney Medical
- Decision
- Substantially Equivalent
- Date received
- 1993-02-12
- Decision date
- 1993-08-07
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assi recall (Z-2022-2012) | LMA North America Inc | 2012-07-17 |