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FDA 510(k)

REGULATOR, PRESSURE, EXPIRATORY

K-Number: K770766 · 1977-05-10

ApplicantGlobe Safety Products, Inc.
Decision Date1977-05-10
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REGULATOR, PRESSURE, EXPIRATORY is the device name listed in this FDA 510(k) record. The listed applicant is Globe Safety Products, Inc.. It received FDA 510(k) clearance on 1977-05-10 under 510(k) number K770766. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGULATOR, PRESSURE, EXPIRATORY?

REGULATOR, PRESSURE, EXPIRATORY is a medical device that received FDA 510(k) clearance on 1977-05-10. The listed applicant is Globe Safety Products, Inc.. The 510(k) number is K770766.

When did REGULATOR, PRESSURE, EXPIRATORY receive FDA 510(k) clearance?

REGULATOR, PRESSURE, EXPIRATORY received FDA 510(k) clearance on 1977-05-10, under 510(k) number K770766.

Who is the listed applicant for REGULATOR, PRESSURE, EXPIRATORY?

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

What is the FDA product code for REGULATOR, PRESSURE, EXPIRATORY?

The FDA product code for REGULATOR, PRESSURE, EXPIRATORY is BYE.

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.

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Other records listing Globe Safety Products, 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.

K890115AMBI-DEX (LATEX EXAMINATION GLOVES)

Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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