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FDA 510(k)

OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE

K-Number: K770426 · 1977-03-15

ApplicantBel-Med, Inc.
Decision Date1977-03-15
Product CodeCAM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE is the device name listed in this FDA 510(k) record. The listed applicant is Bel-Med, Inc.. It received FDA 510(k) clearance on 1977-03-15 under 510(k) number K770426. The device is classified under product code CAM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE?

OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE is a medical device that received FDA 510(k) clearance on 1977-03-15. The listed applicant is Bel-Med, Inc.. The 510(k) number is K770426.

When did OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE receive FDA 510(k) clearance?

OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE received FDA 510(k) clearance on 1977-03-15, under 510(k) number K770426.

Who is the listed applicant for OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE?

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

What is the FDA product code for OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE?

The FDA product code for OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE is CAM.

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 Bel-Med, 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.

K821801NORSEN DEBRIDER

Related Devices (Code: CAM)

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.

K935283YOKE ASSEMBLY MEDICAL GASAmerican Gage & Medical, Inc.K851217PENOX DUAL FLOW MINIFOLDPenox Technologies, Inc.K851216PENOX DUAL FEED MANIFOLDPenox Technologies, Inc.K851215T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTERPenox Technologies, Inc.K851219FILL HOSE SAFETY ADAPTERPenox Technologies, Inc.K840326GAS SUPPLY MANIFOLD SIEMENS-ELEMA ABSiemens Elema AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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