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)

OXYGEN/NITROUS OXIDE OUTLET

K-Number: K780365 · 1978-03-30

ApplicantSpica, Inc.
Decision Date1978-03-30
Product CodeCAM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN/NITROUS OXIDE OUTLET is the device name listed in this FDA 510(k) record. The listed applicant is Spica, Inc.. It received FDA 510(k) clearance on 1978-03-30 under 510(k) number K780365. 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/NITROUS OXIDE OUTLET?

OXYGEN/NITROUS OXIDE OUTLET is a medical device that received FDA 510(k) clearance on 1978-03-30. The listed applicant is Spica, Inc.. The 510(k) number is K780365.

When did OXYGEN/NITROUS OXIDE OUTLET receive FDA 510(k) clearance?

OXYGEN/NITROUS OXIDE OUTLET received FDA 510(k) clearance on 1978-03-30, under 510(k) number K780365.

Who is the listed applicant for OXYGEN/NITROUS OXIDE OUTLET?

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

What is the FDA product code for OXYGEN/NITROUS OXIDE OUTLET?

The FDA product code for OXYGEN/NITROUS OXIDE OUTLET 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 Spica, 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.

K800801ANALGESIA UNITS, OXYGEN & NITRATE DEVICEK780364MANIFOLD KIT

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

View on FDA Database →

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

↑