IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
FDA 510(k) clearance K964977 · decided 1998-08-31
Clearance details
- K-number
- K964977
- Device name
- IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
- Applicant
- Interactive Living Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-12
- Decision date
- 1998-08-31
- Days to decision
- 627 days
- Clearance type
- Traditional
- Product code
- LFF
- Device class
- 1
- Regulation number
- 890.3920
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Aurora, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.