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FDA 510(k)

MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-

K-Number: K821182 · 1982-05-13

ApplicantMachida America, Inc.
Decision Date1982-05-13
Product CodeEQN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- is the device name listed in this FDA 510(k) record. The listed applicant is Machida America, Inc.. It received FDA 510(k) clearance on 1982-05-13 under 510(k) number K821182. The device is classified under product code EQN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-?

MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Machida America, Inc.. The 510(k) number is K821182.

When did MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- receive FDA 510(k) clearance?

MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- received FDA 510(k) clearance on 1982-05-13, under 510(k) number K821182.

Who is the listed applicant for MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-?

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

What is the FDA product code for MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-?

The FDA product code for MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- is EQN.

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Other records listing Machida America, 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.

K871712MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.K854581MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50K844834MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1K841087FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000K821181FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #K812734MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P

View all 8 devices →

Related Devices (Code: EQN)

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.

K252624KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc.K834172OP-CON SURG. INSTRUMENT #7Imm Enterprises , Ltd.K831255LARYNGOSCOPE ATTACHMENT PH2000Eder Instrument Co, Inc.K830888COOL-LITE FIBERCOPTIC LARYNGEAL EXAMNational Medical TechnologyK822525LARYNGOSCOPES RIGIDKelleher Corp.K821707NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHTKelleher Corp.

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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