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FDA 510(k)

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM

K-Number: K010031 · 2001-03-20

ApplicantWescor, Inc.
Decision Date2001-03-20
Product CodeKTB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wescor, Inc.. It received FDA 510(k) clearance on 2001-03-20 under 510(k) number K010031. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM?

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Wescor, Inc.. The 510(k) number is K010031.

When did NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM receive FDA 510(k) clearance?

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM received FDA 510(k) clearance on 2001-03-20, under 510(k) number K010031.

Who is the listed applicant for NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM?

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

What is the FDA product code for NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM?

The FDA product code for NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM is KTB.

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Other records listing Wescor, 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.

K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICK863395WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZERK881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERK881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAYK880544WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAYK853973WESCOR MODEL 3700 WEBSTER SWEAT INDUCER

View all 13 devices →

Related Devices (Code: KTB)

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.

K180627Macroduct Advanced Model 3710Elitechgroup, Inc.K033192RH-950Iomed, Inc.K031551NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)Vyteris, Inc.K031115RH-900Iomed, Inc.K001522TRANSQ3Iomed, Inc.K001410PHORESOR MODEL PM2000Iomed, 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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