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FDA 510(k)

BCI 3403 SLEEP SCREENING PULSE OXIMETER

K-Number: K011156 · 2001-06-14

ApplicantBci, Inc.
Decision Date2001-06-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BCI 3403 SLEEP SCREENING PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bci, Inc.. It received FDA 510(k) clearance on 2001-06-14 under 510(k) number K011156. 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 BCI 3403 SLEEP SCREENING PULSE OXIMETER?

BCI 3403 SLEEP SCREENING PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2001-06-14. The listed applicant is Bci, Inc.. The 510(k) number is K011156.

When did BCI 3403 SLEEP SCREENING PULSE OXIMETER receive FDA 510(k) clearance?

BCI 3403 SLEEP SCREENING PULSE OXIMETER received FDA 510(k) clearance on 2001-06-14, under 510(k) number K011156.

Who is the listed applicant for BCI 3403 SLEEP SCREENING PULSE OXIMETER?

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

What is the FDA product code for BCI 3403 SLEEP SCREENING PULSE OXIMETER?

The FDA product code for BCI 3403 SLEEP SCREENING PULSE OXIMETER is DQA.

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Other records listing Bci, 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.

K030407ADVISOR, MODEL 9200K031742BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETERK020739BCI 3178 PEDIATRIC PULSE OXIMETRY SENSORK020350BCI 3180 PULSE OXIMETERK013862BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAMK0131713420 DIGIT PULSE OXIMETER, MODEL 3420

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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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