FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESOPHAGEAL INTUBATION DETECTOR BULB
K Number: K942628
·
Decision Aug 18, 1994
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- ESOPHAGEAL INTUBATION DETECTOR BULB
- K Number
- K942628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wolfe Tory Medical, Inc.
- Date Received
- June 2, 1994
- Decision Date
- August 18, 1994
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Wolfe Tory Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021044 | MADETT | Sep 11, 2002 | Substantially Equivalent |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Sep 18, 2000 | Substantially Equivalent |
| K990556 | ESOPHAGEAL INTUBATION DETECTOR | Mar 26, 1999 | Substantially Equivalent |
| K945745 | ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) | Dec 7, 1994 | Substantially Equivalent |