FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OHIO VOLUME INCENTIVE SPIROMETER
K Number: K813476
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
13
Review Days
30
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Basic Information
- Device Name
- OHIO VOLUME INCENTIVE SPIROMETER
- K Number
- K813476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Airco/Ohio Medical Products
- Date Received
- December 1, 1981
- Decision Date
- December 31, 1981
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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Other Clearances by Airco/Ohio Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K833459 | COAXIAL VOL. VENTILATOR CIRCUIT | Jan 10, 1984 | Substantially Equivalent |
| 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 |
| 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 |