URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
FDA 510(k) clearance K903816 · decided 1990-10-31
Clearance details
- K-number
- K903816
- Device name
- URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
- Applicant
- Respiratory Support Products, Inc.
- Decision
- Unknown
- Date received
- 1990-08-20
- Decision date
- 1990-10-31
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- EZK
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| E-Z-EM ENTEROCLYSIS CATHETER SET (K911349) | E-Z-Em, Inc. | 1992-11-16 |
| KARAYA GUM POWDER, OSTOMY (K770408) | Howmedica Corp. | 1977-03-15 |
Recalls involving this device
No recalls on record reference this clearance.