FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COAXIAL VOL. VENTILATOR CIRCUIT
K Number: K833459
·
Decision Jan 10, 1984
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
13
Review Days
97
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Basic Information
- Device Name
- COAXIAL VOL. VENTILATOR CIRCUIT
- K Number
- K833459
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Airco/Ohio Medical Products
- Date Received
- October 5, 1983
- Decision Date
- January 10, 1984
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
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PRIMA VOLUMN VENTILATORSS
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Other Clearances by Airco/Ohio Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K833452 | OHIO GMS ABSORBER | Nov 29, 1983 | Substantially Equivalent |
| K832418 | OHIO TEMPERATURE SIMULATOR | Sep 12, 1983 | Substantially Equivalent |
| K832565 | OHIO 5400 VOLUME MONITOR | Sep 1, 1983 | Substantially Equivalent |
| K832185 | OHIO MODEL 922 SPIROMETER | Aug 12, 1983 | Substantially Equivalent |
| K830446 | OXYGEN MONITOR OHIO 5100 | Mar 24, 1983 | Substantially Equivalent |
| K822456 | OHIO V5A ANESTHESIA VENTILATOR | Sep 21, 1982 | Substantially Equivalent |
| K813476 | OHIO VOLUME INCENTIVE SPIROMETER | Dec 31, 1981 | Substantially Equivalent |
| K812879 | OHIO NON-REUSABLE TRACHEAL TUBE MURPHY | Nov 24, 1981 | Substantially Equivalent |
| K812880 | OHIO NON-REUSABLE TRACHEAL TUBE MAJILL | Nov 24, 1981 | Substantially Equivalent |
| K811413 | DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR | Jun 2, 1981 | Substantially Equivalent |