FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER, PO2, INTRAVASUCLAR, CITADEL
K Number: K771116
·
Decision Sep 15, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
22
Applicant Total
62
Review Days
91
Basic Information
- Device Name
- CATHETER, PO2, INTRAVASUCLAR, CITADEL
- K Number
- K771116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1200
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- SHERWOOD MEDICAL INDUSTRIES
- Date Received
- June 16, 1977
- Decision Date
- September 15, 1977
- Product Code
- CCE
- 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 |
|---|---|---|---|
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K782077 | LANCER ICE CUBE | Apr 3, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |