FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
K Number: K903816
·
Decision Oct 31, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
27
Review Days
72
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Basic Information
- Device Name
- URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
- K Number
- K903816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Respiratory Support Products, Inc.
- Date Received
- August 20, 1990
- Decision Date
- October 31, 1990
- Product Code
- EZK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EZK | Catheter, Retention Type | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZK), ordered by most recent decision date.
E-Z-EM ENTEROCLYSIS CATHETER SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARAYA GUM POWDER, OSTOMY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Respiratory Support Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983862 | CLOUD 1 HUMIDIFICATION SYSTEM | May 24, 1999 | Substantially Equivalent |
| K921190 | ADAP-TEMP TEMPERATURE SENSOR ADAPTER | Mar 9, 1993 | Substantially Equivalent |
| K920469 | MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE | Sep 11, 1992 | Substantially Equivalent |
| K921510 | GAS SAMPLING KIT MODIFICATION | Jun 11, 1992 | Substantially Equivalent |
| K913082 | BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D | Dec 11, 1991 | Substantially Equivalent |
| K913083 | BI-TEMP TEMPERATURE MONITOR TM-201D | Oct 17, 1991 | Substantially Equivalent |
| K912280 | BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D | Oct 17, 1991 | Substantially Equivalent |
| K874694 | ADAP-TEMP, MODEL: AT-100 | Mar 1, 1988 | Substantially Equivalent |
| K873472 | MEMBRANE HUMIDIFIER | Jan 19, 1988 | Substantially Equivalent |
| K873205 | TYMPANIC TEMPERATURE SENSOR | Jan 14, 1988 | Substantially Equivalent |