DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM— 510(k) K944833
Substantially EquivalentNew England Medical Monitoring Co.
FDA 510(k) clearance K944833 for DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM, Substantially Equivalent on 1995-05-04. Applicant: New England Medical Monitoring Co.. Device class: 2.
Clearance details
- Applicant
- New England Medical Monitoring Co.
- Product code
- Product 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
Recent devices under product code OMB
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