FDA 510(k)

SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

K-Number: K092950 · 2010-03-12

ApplicantSolaris Medical Technology, Inc.

Decision Date2010-03-12

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Solaris Medical Technology, Inc.. It received FDA 510(k) clearance on 2010-03-12 under 510(k) number K092950. 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 SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES?

SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES is a medical device that received FDA 510(k) clearance on 2010-03-12. The listed applicant is Solaris Medical Technology, Inc.. The 510(k) number is K092950.

When did SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES receive FDA 510(k) clearance?

SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES received FDA 510(k) clearance on 2010-03-12, under 510(k) number K092950.

Who is the listed applicant for SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES?

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

What is the FDA product code for SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES?

The FDA product code for SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Solaris Medical Technology, Inc. as applicant

K100077NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 K101972SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS K073249SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES K061931SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101

Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse 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 Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® 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.