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FDA 510(k)

FRASER SWEATMAN'S DOUBLE MASK

K-Number: K761140 · 1976-12-09

ApplicantFraser Sweatman, Inc.
Decision Date1976-12-09
Product CodeCBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FRASER SWEATMAN'S DOUBLE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Fraser Sweatman, Inc.. It received FDA 510(k) clearance on 1976-12-09 under 510(k) number K761140. 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 FRASER SWEATMAN'S DOUBLE MASK?

FRASER SWEATMAN'S DOUBLE MASK is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Fraser Sweatman, Inc.. The 510(k) number is K761140.

When did FRASER SWEATMAN'S DOUBLE MASK receive FDA 510(k) clearance?

FRASER SWEATMAN'S DOUBLE MASK received FDA 510(k) clearance on 1976-12-09, under 510(k) number K761140.

Who is the listed applicant for FRASER SWEATMAN'S DOUBLE MASK?

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

What is the FDA product code for FRASER SWEATMAN'S DOUBLE MASK?

The FDA product code for FRASER SWEATMAN'S DOUBLE MASK is CBN.

Related Clinical Trials

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Other records listing Fraser Sweatman, 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.

K771299EMERGENCY OXYGEN RESUSCITATORK770911MEDISHIELD JORDON LIFTING FRAMEK770910MEDISHIELD CERVICAL COLLARK760766PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXERK760076ABSORBER, ANESTHESIA CIRCLE SYS, CO2

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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