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FDA 510(k)

RESPIRATOR/GILL 1/SIMV

K-Number: K781706 · 1979-01-22

ApplicantChemetron Medical Products, Inc.
Decision Date1979-01-22
Product CodeCBO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATOR/GILL 1/SIMV is the device name listed in this FDA 510(k) record. The listed applicant is Chemetron Medical Products, Inc.. It received FDA 510(k) clearance on 1979-01-22 under 510(k) number K781706. The device is classified under product code CBO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATOR/GILL 1/SIMV?

RESPIRATOR/GILL 1/SIMV is a medical device that received FDA 510(k) clearance on 1979-01-22. The listed applicant is Chemetron Medical Products, Inc.. The 510(k) number is K781706.

When did RESPIRATOR/GILL 1/SIMV receive FDA 510(k) clearance?

RESPIRATOR/GILL 1/SIMV received FDA 510(k) clearance on 1979-01-22, under 510(k) number K781706.

Who is the listed applicant for RESPIRATOR/GILL 1/SIMV?

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

What is the FDA product code for RESPIRATOR/GILL 1/SIMV?

The FDA product code for RESPIRATOR/GILL 1/SIMV is CBO.

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 Chemetron Medical 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.

K781537NEBULIZER/HUMIDIFIERK781542HEATED NEBULIZERK781541FLOMETER

Related Devices (Code: CBO)

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.

K811991SIMVACThe Lynn Terrell Co.K811908IMV MANIFOLDSAirlife, Inc.K791904IMV W/BAG & HOSES #M-509Mem Medical, Inc.K791909IMV BUSHING #M-513Mem Medical, Inc.K791912IMV FOR MONITORING #M-510Mem Medical, Inc.K791913IMV MANIFOLD #M-506Mem 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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