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FDA 510(k)

FLEX BLUE

K-Number: K950318 · 1995-02-13

ApplicantKing Systems Corp.
Decision Date1995-02-13
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEX BLUE is the device name listed in this FDA 510(k) record. The listed applicant is King Systems Corp.. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K950318. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX BLUE?

FLEX BLUE is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is King Systems Corp.. The 510(k) number is K950318.

When did FLEX BLUE receive FDA 510(k) clearance?

FLEX BLUE received FDA 510(k) clearance on 1995-02-13, under 510(k) number K950318.

Who is the listed applicant for FLEX BLUE?

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

What is the FDA product code for FLEX BLUE?

The FDA product code for FLEX BLUE is CBH.

Other records listing King Systems Corp. 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.

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105K012485MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCEK010040SLEEVED FILTERK990614HME-BOOSTER

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Related Devices (Code: CBH)

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.

K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.K950930TRACHE-TITEThe Varner Group, Inc.K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products Corp.K934288HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BARNeo-Tech, 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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