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FDA 510(k)

OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830

K-Number: K010747 · 2001-05-16

ApplicantWestern Ent.
Decision Date2001-05-16
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 is the device name listed in this FDA 510(k) record. The listed applicant is Western Ent.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K010747. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830?

OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Western Ent.. The 510(k) number is K010747.

When did OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 receive FDA 510(k) clearance?

OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 received FDA 510(k) clearance on 2001-05-16, under 510(k) number K010747.

Who is the listed applicant for OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830?

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

What is the FDA product code for OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830?

The FDA product code for OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 is NFB.

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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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