FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGEN CONSUMPTION MONITOR #OCM-0100
K Number: K823359
·
Decision Jan 5, 1983
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
55
Review Days
61
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Basic Information
- Device Name
- OXYGEN CONSUMPTION MONITOR #OCM-0100
- K Number
- K823359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bentley Laboratories, Inc.
- Date Received
- November 5, 1982
- Decision Date
- January 5, 1983
- Product Code
- DRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | Feb 2, 1988 | Substantially Equivalent |
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| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | Jan 19, 1988 | Substantially Equivalent |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | Jan 5, 1983 | Substantially Equivalent |
| K823456 | OXYGENATORS #BOS-10, 105, 5S | Dec 30, 1982 | Substantially Equivalent |