510(k) K941325
K941325 is an FDA 510(k) premarket notification submitted by Strong Medical, Inc. for the device "WATER IRRIGATOR, W1 200". The FDA issued a decision of Substantially Equivalent on August 9, 1994. The device falls under product code KHH (Stimulator, Caloric-Air), a Class I device regulated under 21 CFR 874.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 1994
- Date Received
- March 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Caloric-Air
- Device Class
- Class I
- Regulation Number
- 874.1800
- Review Panel
- EN
- Submission Type