510(k) K880391
K880391 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "DACOMED CYSTOMETER". The FDA issued a decision of Substantially Equivalent on April 27, 1988. The device falls under product code EXQ (Cystometer, Electrical Recording), a Class II device regulated under 21 CFR 876.1620. Dacomed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 1988
- Date Received
- January 29, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cystometer, Electrical Recording
- Device Class
- Class II
- Regulation Number
- 876.1620
- Review Panel
- GU
- Submission Type