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FDA 510(k)

OHMEDA 3800 PULSE OXIMETER

K-Number: K962127 · 1996-10-10

ApplicantOhmeda Medical
Decision Date1996-10-10
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OHMEDA 3800 PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1996-10-10 under 510(k) number K962127. 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 OHMEDA 3800 PULSE OXIMETER?

OHMEDA 3800 PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1996-10-10. The listed applicant is Ohmeda Medical. The 510(k) number is K962127.

When did OHMEDA 3800 PULSE OXIMETER receive FDA 510(k) clearance?

OHMEDA 3800 PULSE OXIMETER received FDA 510(k) clearance on 1996-10-10, under 510(k) number K962127.

Who is the listed applicant for OHMEDA 3800 PULSE OXIMETER?

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

What is the FDA product code for OHMEDA 3800 PULSE OXIMETER?

The FDA product code for OHMEDA 3800 PULSE OXIMETER is DQA.

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Other records listing Ohmeda Medical 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.

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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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