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FDA 510(k)

DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM

K-Number: K944833 · 1995-05-04

ApplicantNew England Medical Monitoring Co.
Decision Date1995-05-04
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is New England Medical Monitoring Co.. It received FDA 510(k) clearance on 1995-05-04 under 510(k) number K944833. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM?

DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is New England Medical Monitoring Co.. The 510(k) number is K944833.

When did DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM receive FDA 510(k) clearance?

DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM received FDA 510(k) clearance on 1995-05-04, under 510(k) number K944833.

Who is the listed applicant for DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM?

The FDA 510(k) record lists New England Medical Monitoring Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM?

The FDA product code for DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM is OMB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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