FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U-FLOAT VALVE 2D9023
K Number: K781467
·
Decision Sep 7, 1978
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
206
Review Days
14
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Basic Information
- Device Name
- U-FLOAT VALVE 2D9023
- K Number
- K781467
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Travenol Laboratories, S.A.
- Date Received
- August 24, 1978
- Decision Date
- September 7, 1978
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Travenol Laboratories, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K874181 | BAXTER BEDSIDE SYSTEM | Feb 22, 1988 | Substantially Equivalent |
| K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE | Nov 5, 1987 | Substantially Equivalent |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | Oct 22, 1987 | Substantially Equivalent |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | Oct 20, 1987 | Substantially Equivalent |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Oct 13, 1987 | Substantially Equivalent |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | Sep 30, 1987 | Substantially Equivalent |
| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | Sep 4, 1987 | Substantially Equivalent |
| K871908 | IV ADMINISTRATION SET | Jul 27, 1987 | Substantially Equivalent |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Apr 17, 1987 | Substantially Equivalent |