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FDA 510(k)

DURA-Y OXYGEN TRANSDUCER, EAR CLIP

K-Number: K944760 · 1994-10-17

ApplicantNellcor, Inc.
Decision Date1994-10-17
Product CodeDPZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DURA-Y OXYGEN TRANSDUCER, EAR CLIP is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor, Inc.. It received FDA 510(k) clearance on 1994-10-17 under 510(k) number K944760. The device is classified under product code DPZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURA-Y OXYGEN TRANSDUCER, EAR CLIP?

DURA-Y OXYGEN TRANSDUCER, EAR CLIP is a medical device that received FDA 510(k) clearance on 1994-10-17. The listed applicant is Nellcor, Inc.. The 510(k) number is K944760.

When did DURA-Y OXYGEN TRANSDUCER, EAR CLIP receive FDA 510(k) clearance?

DURA-Y OXYGEN TRANSDUCER, EAR CLIP received FDA 510(k) clearance on 1994-10-17, under 510(k) number K944760.

Who is the listed applicant for DURA-Y OXYGEN TRANSDUCER, EAR CLIP?

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

What is the FDA product code for DURA-Y OXYGEN TRANSDUCER, EAR CLIP?

The FDA product code for DURA-Y OXYGEN TRANSDUCER, EAR CLIP is DPZ.

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Other records listing Nellcor, 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.

K953472NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITORK952316NELLCOR SYMPHONY N-3000 PULSE OXIMETERK952222NELLCOR N-20PA PORTABLE PULSE OXIMETERK942347NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000K945947NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETERK944400PEDI-CAP

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Related Devices (Code: DPZ)

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.

K042675FLEXI-STAT SP02 EAR SENSORElekon Industries U.S.A., Inc.K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.K012333FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K010718FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K942752MARQUETTE EAR PROBE SENSORMarquette Electronics, Inc.K914595PULSE RATE MONITORFitness Quest, Inc.

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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