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FDA 510(k)

PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)

K-Number: K965239 · 1997-03-28

ApplicantAccutron, Inc.
Decision Date1997-03-28
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) is the device name listed in this FDA 510(k) record. The listed applicant is Accutron, Inc.. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K965239. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)?

PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Accutron, Inc.. The 510(k) number is K965239.

When did PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) receive FDA 510(k) clearance?

PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) received FDA 510(k) clearance on 1997-03-28, under 510(k) number K965239.

Who is the listed applicant for PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)?

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

What is the FDA product code for PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)?

The FDA product code for PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) is CBN.

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 Accutron, 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.

K052335ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRAK033503RFS VACUUM GAUGE SCAVENGING CIRCUITK992421GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076K970046UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)

Related Devices (Code: CBN)

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.

K223452Nitronox Scavenger PlusParker Hannifin CorporationK193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.K160950MINISCAVSedation Systems, LLCK123176ISO-GARD CLEARAIR MASKTeleflexmedical, Inc.K110930ACTIVE WASTE GAS SCAVENGERG. Dundas Co.,Inc.K092031VAPOR-CLEAR, MODEL 100Axon Medical, Inc.

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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