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FDA 510(k)

KELLER PULSE OXIMETER, MODEL 850+

K-Number: K982331 · 1998-09-11

ApplicantKeller Medical Specialties Products, Inc.
Decision Date1998-09-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KELLER PULSE OXIMETER, MODEL 850+ is the device name listed in this FDA 510(k) record. The listed applicant is Keller Medical Specialties Products, Inc.. It received FDA 510(k) clearance on 1998-09-11 under 510(k) number K982331. 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 KELLER PULSE OXIMETER, MODEL 850+?

KELLER PULSE OXIMETER, MODEL 850+ is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Keller Medical Specialties Products, Inc.. The 510(k) number is K982331.

When did KELLER PULSE OXIMETER, MODEL 850+ receive FDA 510(k) clearance?

KELLER PULSE OXIMETER, MODEL 850+ received FDA 510(k) clearance on 1998-09-11, under 510(k) number K982331.

Who is the listed applicant for KELLER PULSE OXIMETER, MODEL 850+?

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

What is the FDA product code for KELLER PULSE OXIMETER, MODEL 850+?

The FDA product code for KELLER PULSE OXIMETER, MODEL 850+ is DQA.

Related Clinical Trials

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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Other records listing Keller Medical Specialties Products, 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.

K990648KELLER VITAL SIGNS MONITOR, KMS 890+K914576KELLER CARDIAC MONITOR MEDIL KMS870K910262KELLER VITAL SIGNS MONITOR - KMS-890K903437DISPOS ACCESS EXTERNAL CARDIAC PACEMAKERK895987KELLER PULSE OXIMETER - KMS 850

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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