510(k) K964977
- Device
- IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
- Applicant
- INTERACTIVE LIVING SYSTEMS, INC.
- 510(k) number
- K964977
- Product code
- LFF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-08-31
- Date received
- 1996-12-12
- Regulation
- 890.3920
- Classification name
- Unit, Activation, Breath Control
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ORVILLE K HOLLENBECK
- Address
- 14901 E. Hampden Ave., Suite 310 Aurora CO US 80014 80014
FDA Registration Numbers
- 1531186
- 3009488700
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases