FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALVE, PRESSURE, DEMAND
K Number: K770665
·
Decision Apr 15, 1977
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
8
Review Days
7
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Basic Information
- Device Name
- VALVE, PRESSURE, DEMAND
- K Number
- K770665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mcgaw Respiratory Therapy
- Date Received
- April 8, 1977
- Decision Date
- April 15, 1977
- Product Code
- CBD
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| CBD | Bottle, Collection, Breathing System (Calibrated) | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBD), ordered by most recent decision date.
IMV SYSTEM
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FDA 510(k)
FDA Class 2
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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 |
| 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 |
| K760998 | ENDOTRACHAEL TUBE AND HOLDER | Nov 19, 1976 | Substantially Equivalent |