DIGITRACE HOME VIDEO SYSTEM— 510(k) K955787
Substantially EquivalentNew England Medical Instruments, Inc.
FDA 510(k) clearance K955787 for DIGITRACE HOME VIDEO SYSTEM, Substantially Equivalent on 1996-02-09. Applicant: New England Medical Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- New England Medical Instruments, Inc.
- Product code
- Code OMB
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
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