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FDA 510(k)

RESPIRATORY THERAPY GAS POUCH

K-Number: K781980 · 1978-12-07

ApplicantMedicare Industries, Inc.
Decision Date1978-12-07
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY THERAPY GAS POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Medicare Industries, Inc.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K781980. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY THERAPY GAS POUCH?

RESPIRATORY THERAPY GAS POUCH is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Medicare Industries, Inc.. The 510(k) number is K781980.

When did RESPIRATORY THERAPY GAS POUCH receive FDA 510(k) clearance?

RESPIRATORY THERAPY GAS POUCH received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781980.

Who is the listed applicant for RESPIRATORY THERAPY GAS POUCH?

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

What is the FDA product code for RESPIRATORY THERAPY GAS POUCH?

The FDA product code for RESPIRATORY THERAPY GAS POUCH is FRG.

Related Clinical Trials

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Other records listing Medicare Industries, 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.

K894197LATEX EXAMINATION GLOVESK891865NIL (PATIENT EXAMINATION GLOVES - LATEX)K791434SPONGE COUNTER BAGSK781981DECONTAMINATION ITEMS BAGK781925POUCHES, GAS STERILIZATIONK781924POUCHES AND TUBING, MEDI-SEAL

View all 7 devices →

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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