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FDA 510(k)

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II

K-Number: K012715 · 2003-08-01

ApplicantHygia Health Services, Inc.
Decision Date2003-08-01
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II is the device name listed in this FDA 510(k) record. The listed applicant is Hygia Health Services, Inc.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K012715. The device is classified under product code NLF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II?

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Hygia Health Services, Inc.. The 510(k) number is K012715.

When did HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II receive FDA 510(k) clearance?

HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II received FDA 510(k) clearance on 2003-08-01, under 510(k) number K012715.

Who is the listed applicant for HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II?

The FDA 510(k) record lists Hygia Health Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II?

The FDA product code for HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II is NLF.

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Other records listing Hygia Health Services, 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.

K100523ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USAK090074HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFSK080424HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861K053575HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFSK041867HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-NK032821HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF

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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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