510(k) K964977
K964977 is an FDA 510(k) premarket notification submitted by Interactive Living Systems, Inc. for the device "IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)". The FDA issued a decision of Substantially Equivalent on August 31, 1998. The device falls under product code LFF (Unit, Activation, Breath Control), a Class I device regulated under 21 CFR 890.3920.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1998
- Date Received
- December 12, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Activation, Breath Control
- Device Class
- Class I
- Regulation Number
- 890.3920
- Review Panel
- PM
- Submission Type