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FDA 510(k)

TRAY, BLOOD GAS, CAT. NO. 4010

K-Number: K770361 · 1977-04-05

ApplicantConcord Laboratories, Inc.
Decision Date1977-04-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRAY, BLOOD GAS, CAT. NO. 4010 is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770361. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAY, BLOOD GAS, CAT. NO. 4010?

TRAY, BLOOD GAS, CAT. NO. 4010 is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K770361.

When did TRAY, BLOOD GAS, CAT. NO. 4010 receive FDA 510(k) clearance?

TRAY, BLOOD GAS, CAT. NO. 4010 received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770361.

Who is the listed applicant for TRAY, BLOOD GAS, CAT. NO. 4010?

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

What is the FDA product code for TRAY, BLOOD GAS, CAT. NO. 4010?

The FDA product code for TRAY, BLOOD GAS, CAT. NO. 4010 is FMF.

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Other records listing Concord Laboratories, 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.

K883840DRI-VENT ARTERIAL BLOOD SAMPLING KITK871825MECONIUM SUCTION CATHETERK864535TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110K862039CONCORD CARE TRAYK854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATHK854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLES

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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