510(k) K881630
K881630 is an FDA 510(k) premarket notification submitted by Ics Medical Corp. for the device "AUTOMATIC CALORIC IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 21, 1988. The device falls under product code KHH (Stimulator, Caloric-Air), a Class I device regulated under 21 CFR 874.1800. Ics Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1988
- Date Received
- April 14, 1988
- 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