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FDA 510(k)

NELLCOR SYMPHONY N-3000 PULSE OXIMETER

K-Number: K952316 · 1995-08-17

ApplicantNellcor, Inc.
Decision Date1995-08-17
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NELLCOR SYMPHONY N-3000 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor, Inc.. It received FDA 510(k) clearance on 1995-08-17 under 510(k) number K952316. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NELLCOR SYMPHONY N-3000 PULSE OXIMETER?

NELLCOR SYMPHONY N-3000 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1995-08-17. The listed applicant is Nellcor, Inc.. The 510(k) number is K952316.

When did NELLCOR SYMPHONY N-3000 PULSE OXIMETER receive FDA 510(k) clearance?

NELLCOR SYMPHONY N-3000 PULSE OXIMETER received FDA 510(k) clearance on 1995-08-17, under 510(k) number K952316.

Who is the listed applicant for NELLCOR SYMPHONY N-3000 PULSE OXIMETER?

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 NELLCOR SYMPHONY N-3000 PULSE OXIMETER?

The FDA product code for NELLCOR SYMPHONY N-3000 PULSE OXIMETER is DQA.

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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 MONITORK952222NELLCOR 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 OXIMETERK944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPK944400PEDI-CAP

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Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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