FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOWMETER, OXYGEN
K Number: K760314
·
Decision Aug 4, 1976
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
23
Applicant Total
7
Review Days
9
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Basic Information
- Device Name
- FLOWMETER, OXYGEN
- K Number
- K760314
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Harris-Lake, Inc.
- Date Received
- July 26, 1976
- Decision Date
- August 4, 1976
- Product Code
- CAX
- 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 |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | FDA class 1 | Anesthesiology |
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Other Clearances by Harris-Lake, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K761293 | RESPIRATORY HUMIDIFIER | Jan 3, 1977 | Substantially Equivalent |
| K761294 | RESPIRATORY BLOWER | Jan 3, 1977 | Substantially Equivalent |
| K761295 | RESP. AIR TEMP. CONTROL & HAZARD MON. | Dec 30, 1976 | Substantially Equivalent |
| K760333 | JAR, COLLECTOR FOR SUCTION SYSTEMS | Oct 27, 1976 | Substantially Equivalent |
| K760316 | REGULATORS, LOW SUCTION | Aug 4, 1976 | Substantially Equivalent |
| K760317 | REGULATORS, HIGH SUCTION | Aug 4, 1976 | Substantially Equivalent |