FDA 510(k)

SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS

K-Number: K101972 · 2010-07-22

ApplicantSolaris Medical Technology, Inc.

Decision Date2010-07-22

Product CodeDXQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS 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 2010-07-22 under 510(k) number K101972. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS?

SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS is a medical device that received FDA 510(k) clearance on 2010-07-22. The listed applicant is Solaris Medical Technology, Inc.. The 510(k) number is K101972.

When did SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS receive FDA 510(k) clearance?

SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS received FDA 510(k) clearance on 2010-07-22, under 510(k) number K101972.

Who is the listed applicant for SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS?

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 REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS?

The FDA product code for SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS is DXQ.

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Other records listing Solaris Medical Technology, Inc. as applicant

K100077NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 K092950SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES 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: DXQ)

K254287Medline Reusable Blood Pressure CuffMedline Industries, LP K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation K253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare Corporation K250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

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.