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FDA 510(k)

T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER

K-Number: K851215 · 1985-06-18

ApplicantPenox Technologies, Inc.
Decision Date1985-06-18
Product CodeCAM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Penox Technologies, Inc.. It received FDA 510(k) clearance on 1985-06-18 under 510(k) number K851215. 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 T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER?

T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER is a medical device that received FDA 510(k) clearance on 1985-06-18. The listed applicant is Penox Technologies, Inc.. The 510(k) number is K851215.

When did T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER receive FDA 510(k) clearance?

T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER received FDA 510(k) clearance on 1985-06-18, under 510(k) number K851215.

Who is the listed applicant for T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER?

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

What is the FDA product code for T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER?

The FDA product code for T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER is CAM.

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Other records listing Penox Technologies, 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.

K864667PENOX HOSPITAL BEDK863978PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)K862654MODIFIED PENOX LIFT CHAIRK853775PENOX HIGH FLOW MANIFOLDK852109PENOX PERFORMER WHEELCHAIRK851218PENOX LIFT CHAIR

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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.K851219FILL HOSE SAFETY ADAPTERPenox Technologies, Inc.K840326GAS SUPPLY MANIFOLD SIEMENS-ELEMA ABSiemens Elema ABK780365OXYGEN/NITROUS OXIDE OUTLETSpica, 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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