FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENTILATOR BREATHING CIRCUIT
K Number: K770286
·
Decision Feb 25, 1977
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
8
Review Days
11
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Basic Information
- Device Name
- VENTILATOR BREATHING CIRCUIT
- K Number
- K770286
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mcgaw Respiratory Therapy
- Date Received
- February 14, 1977
- Decision Date
- February 25, 1977
- Product Code
- CAI
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAI), ordered by most recent decision date.
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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 |
| 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 |