Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POGS, MODEL 65/130

K-Number: K092636 · 2010-01-07

ApplicantOn Site Gas Systems, Inc.
Decision Date2010-01-07
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POGS, MODEL 65/130 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 2010-01-07 under 510(k) number K092636. 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 65/130?

POGS, MODEL 65/130 is a medical device that received FDA 510(k) clearance on 2010-01-07. The listed applicant is On Site Gas Systems, Inc.. The 510(k) number is K092636.

When did POGS, MODEL 65/130 receive FDA 510(k) clearance?

POGS, MODEL 65/130 received FDA 510(k) clearance on 2010-01-07, under 510(k) number K092636.

Who is the listed applicant for POGS, MODEL 65/130?

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 65/130?

The FDA product code for POGS, MODEL 65/130 is CAW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K063454POGS, MODEL 33CK041664PORTABLE OXYGEN GENERATION SYSTEM: POGS 33CK030920POGS 33K021581HEMOSORBK013390QUICKCLOTK021082ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0

View all 9 devices →

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.

↑