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FDA 510(k)

BURDICK PRO2 OXIMETER

K-Number: K941351 · 1994-10-13

ApplicantBurdick Corp.
Decision Date1994-10-13
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BURDICK PRO2 OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1994-10-13 under 510(k) number K941351. 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 BURDICK PRO2 OXIMETER?

BURDICK PRO2 OXIMETER is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Burdick Corp.. The 510(k) number is K941351.

When did BURDICK PRO2 OXIMETER receive FDA 510(k) clearance?

BURDICK PRO2 OXIMETER received FDA 510(k) clearance on 1994-10-13, under 510(k) number K941351.

Who is the listed applicant for BURDICK PRO2 OXIMETER?

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

What is the FDA product code for BURDICK PRO2 OXIMETER?

The FDA product code for BURDICK PRO2 OXIMETER is DQA.

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Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK903565E560 ELECTROCARDIOGRAPHK904032ELITE II ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840LK892835E350 ELECTROCARDIOGRAPH

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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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