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FDA 510(k)

DR180-R/OXY

K-Number: K983576 · 1999-03-23

ApplicantNorth East Monitoring, Inc.
Decision Date1999-03-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DR180-R/OXY is the device name listed in this FDA 510(k) record. The listed applicant is North East Monitoring, Inc.. It received FDA 510(k) clearance on 1999-03-23 under 510(k) number K983576. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR180-R/OXY?

DR180-R/OXY is a medical device that received FDA 510(k) clearance on 1999-03-23. The listed applicant is North East Monitoring, Inc.. The 510(k) number is K983576.

When did DR180-R/OXY receive FDA 510(k) clearance?

DR180-R/OXY received FDA 510(k) clearance on 1999-03-23, under 510(k) number K983576.

Who is the listed applicant for DR180-R/OXY?

The FDA 510(k) record lists North East Monitoring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR180-R/OXY?

The FDA product code for DR180-R/OXY is FLL.

Other records listing North East Monitoring, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081861HOLTER LX ANALYSISK070014AUTO DETECT FOR TELAHEART DR200/E-AK061293TELAHEART DIGITAL RECORDERK041901SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDERK004007DR180+OXYK001288DR180-II

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Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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