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FDA 510(k)

OPTI- SYSTEM

K-Number: K810559 · 1981-03-17

ApplicantCorpak Co.
Decision Date1981-03-17
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPTI- SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1981-03-17 under 510(k) number K810559. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI- SYSTEM?

OPTI- SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Corpak Co.. The 510(k) number is K810559.

When did OPTI- SYSTEM receive FDA 510(k) clearance?

OPTI- SYSTEM received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810559.

Who is the listed applicant for OPTI- SYSTEM?

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

What is the FDA product code for OPTI- SYSTEM?

The FDA product code for OPTI- SYSTEM is BTT.

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Other records listing Corpak Co. 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.

K935512CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACOREK931921CORPAK GASTROSTOMY TUBEK932847CORPAK ENTERAL PUMPK902949CORPAK GRASPING FORCEPSK901501CORPAK GASTROSTOMY TUBEK882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE

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Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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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