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FDA 510(k)

POGS, MODEL 33C

K-Number: K063454 · 2007-05-09

ApplicantOn Site Gas Systems, Inc.
Decision Date2007-05-09
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POGS, MODEL 33C is the device name listed in this FDA 510(k) record. The listed applicant is On Site Gas Systems, Inc.. It received FDA 510(k) clearance on 2007-05-09 under 510(k) number K063454. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POGS, MODEL 33C?

POGS, MODEL 33C is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is On Site Gas Systems, Inc.. The 510(k) number is K063454.

When did POGS, MODEL 33C receive FDA 510(k) clearance?

POGS, MODEL 33C received FDA 510(k) clearance on 2007-05-09, under 510(k) number K063454.

Who is the listed applicant for POGS, MODEL 33C?

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

What is the FDA product code for POGS, MODEL 33C?

The FDA product code for POGS, MODEL 33C is CAW.

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Other records listing On Site Gas Systems, 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.

K092636POGS, MODEL 65/130K041664PORTABLE OXYGEN GENERATION SYSTEM: POGS 33CK030920POGS 33K021581HEMOSORBK013390QUICKCLOTK021082ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0

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Related Devices (Code: CAW)

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC

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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