510(k) K874525
K874525 is an FDA 510(k) premarket notification submitted by Mon-A-Therm, Inc. for the device "MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on January 6, 1988. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Mon-A-Therm, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1988
- Date Received
- November 2, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type