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FDA 510(k)

DEMAND FLOW VALVE & SONRA W/NASAL MASK

K-Number: K854571 · 1986-02-10

ApplicantGale E. Dryden
Decision Date1986-02-10
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DEMAND FLOW VALVE & SONRA W/NASAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Gale E. Dryden. It received FDA 510(k) clearance on 1986-02-10 under 510(k) number K854571. 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 DEMAND FLOW VALVE & SONRA W/NASAL MASK?

DEMAND FLOW VALVE & SONRA W/NASAL MASK is a medical device that received FDA 510(k) clearance on 1986-02-10. The listed applicant is Gale E. Dryden. The 510(k) number is K854571.

When did DEMAND FLOW VALVE & SONRA W/NASAL MASK receive FDA 510(k) clearance?

DEMAND FLOW VALVE & SONRA W/NASAL MASK received FDA 510(k) clearance on 1986-02-10, under 510(k) number K854571.

Who is the listed applicant for DEMAND FLOW VALVE & SONRA W/NASAL MASK?

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

What is the FDA product code for DEMAND FLOW VALVE & SONRA W/NASAL MASK?

The FDA product code for DEMAND FLOW VALVE & SONRA W/NASAL MASK is CBN.

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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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