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FDA 510(k)

NEOTECH MECONIUM ASPIRATOR (STERILE)

K-Number: K880487 · 1988-05-06

ApplicantNeotech Products, Inc.
Decision Date1988-05-06
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOTECH MECONIUM ASPIRATOR (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Neotech Products, Inc.. It received FDA 510(k) clearance on 1988-05-06 under 510(k) number K880487. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOTECH MECONIUM ASPIRATOR (STERILE)?

NEOTECH MECONIUM ASPIRATOR (STERILE) is a medical device that received FDA 510(k) clearance on 1988-05-06. The listed applicant is Neotech Products, Inc.. The 510(k) number is K880487.

When did NEOTECH MECONIUM ASPIRATOR (STERILE) receive FDA 510(k) clearance?

NEOTECH MECONIUM ASPIRATOR (STERILE) received FDA 510(k) clearance on 1988-05-06, under 510(k) number K880487.

Who is the listed applicant for NEOTECH MECONIUM ASPIRATOR (STERILE)?

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

What is the FDA product code for NEOTECH MECONIUM ASPIRATOR (STERILE)?

The FDA product code for NEOTECH MECONIUM ASPIRATOR (STERILE) is BTR.

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Other records listing Neotech 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.

K011564NEOLEADK931727URINARY DRAINAGE BAG CADDYK921024URO-TOTE LEG BAGK890425NEOTECH MUCUS TRAP W/CATHETERK882203NEOTECH UNIVERSAL ADAPTER

Related Devices (Code: BTR)

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.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLCK243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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