510(k) K934369
K934369 is an FDA 510(k) premarket notification submitted by Laborie Medical Technologies, Ltd. for the device "DRI SLEEPER". The FDA issued a decision of Substantially Equivalent on November 24, 1993. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Laborie Medical Technologies, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1993
- Date Received
- September 7, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alarm, Conditioned Response Enuresis
- Device Class
- Class II
- Regulation Number
- 876.2040
- Review Panel
- GU
- Submission Type