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FDA 510(k)

PULSE OXIMETER MODEL 305

K-Number: K943842 · 1995-03-24

ApplicantPalco Laboratories, Inc.
Decision Date1995-03-24
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE OXIMETER MODEL 305 is the device name listed in this FDA 510(k) record. The listed applicant is Palco Laboratories, Inc.. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K943842. 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 PULSE OXIMETER MODEL 305?

PULSE OXIMETER MODEL 305 is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Palco Laboratories, Inc.. The 510(k) number is K943842.

When did PULSE OXIMETER MODEL 305 receive FDA 510(k) clearance?

PULSE OXIMETER MODEL 305 received FDA 510(k) clearance on 1995-03-24, under 510(k) number K943842.

Who is the listed applicant for PULSE OXIMETER MODEL 305?

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

What is the FDA product code for PULSE OXIMETER MODEL 305?

The FDA product code for PULSE OXIMETER MODEL 305 is DQA.

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Other records listing Palco Laboratories, 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.

K942810PALCO LABS COLD POUCHK920066PALCO LABS MODEL 340 PULSE OXIMETERK913694PALCO LABS LOADMATICK911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITORK904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITORK872233INJECT-EASE

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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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