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FDA 510(k)

FINGER PULSE METER

K-Number: K000814 · 2001-03-29

ApplicantBhs Intl., Inc.
Decision Date2001-03-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FINGER PULSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Bhs Intl., Inc.. It received FDA 510(k) clearance on 2001-03-29 under 510(k) number K000814. 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 FINGER PULSE METER?

FINGER PULSE METER is a medical device that received FDA 510(k) clearance on 2001-03-29. The listed applicant is Bhs Intl., Inc.. The 510(k) number is K000814.

When did FINGER PULSE METER receive FDA 510(k) clearance?

FINGER PULSE METER received FDA 510(k) clearance on 2001-03-29, under 510(k) number K000814.

Who is the listed applicant for FINGER PULSE METER?

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

What is the FDA product code for FINGER PULSE METER?

The FDA product code for FINGER PULSE METER 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 Bhs Intl., 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.

K940578MANUAL STETOSCOPE

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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