FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOTRACHAEL TUBE AND HOLDER
K Number: K760998
·
Decision Nov 19, 1976
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
8
Review Days
11
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Basic Information
- Device Name
- ENDOTRACHAEL TUBE AND HOLDER
- K Number
- K760998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mcgaw Respiratory Therapy
- Date Received
- November 8, 1976
- Decision Date
- November 19, 1976
- 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 Mcgaw Respiratory Therapy
| K Number | Device Name | ||
|---|---|---|---|
| K771550 | MRT DISPENSOR | Sep 20, 1977 | Substantially Equivalent |
| K771516 | CAPILLARY SAMPLE LINE | Aug 16, 1977 | Substantially Equivalent |
| K770665 | VALVE, PRESSURE, DEMAND | Apr 15, 1977 | Substantially Equivalent |
| K770286 | VENTILATOR BREATHING CIRCUIT | Feb 25, 1977 | Substantially Equivalent |
| K761300 | NEBULIZER CONTROL UNIT | Dec 30, 1976 | Substantially Equivalent |
| K761298 | PRE-FILLED DISPOSABLE NEBULIZER | Dec 30, 1976 | Substantially Equivalent |
| K761299 | DISPOSABLE NEBULIZER | Dec 30, 1976 | Substantially Equivalent |