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FDA 510(k)

MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)

K-Number: K901819 · 1990-07-18

ApplicantHewlett-Packard Co.
Decision Date1990-07-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1990-07-18 under 510(k) number K901819. 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 MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)?

MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) is a medical device that received FDA 510(k) clearance on 1990-07-18. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K901819.

When did MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) receive FDA 510(k) clearance?

MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) received FDA 510(k) clearance on 1990-07-18, under 510(k) number K901819.

Who is the listed applicant for MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)?

The FDA product code for MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) is DQA.

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Other records listing Hewlett-Packard Co. as applicant

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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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