510(k) K894968
K894968 is an FDA 510(k) premarket notification submitted by Eutectic Electronics, Inc. for the device "ULTRACOMPACT". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Eutectic Electronics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1989
- Date Received
- August 7, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Uroflowmeter
- Device Class
- Class II
- Regulation Number
- 876.1800
- Review Panel
- GU
- Submission Type